Pages: 1 [2] 3 4 ... 11   Go Down
Print
Author Topic: Deep brain stimulator - Misc. Adverse Events  (Read 95872 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #30 on: November 05, 2013, 10:45:00 PM »

Model Number IPGNEURO
Device Problem Premature discharge of battery
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

See mfr # 3007566237201010563. The neurostimulator (ins) came up with the end of service message after being implanted for only a few weeks. The impedance measurements were out of range: some high and low readings. The pt did experience clinical benefit from the ins before it switch off. The ins was replaced and returned to the mfr company. Add'l info has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1936624

« Last Edit: November 25, 2013, 08:46:12 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #31 on: November 05, 2013, 10:45:21 PM »

Model Number IPGNEURO
Device Problem Premature discharge of battery
Event Type  Malfunction  
Event Description

See manufacturer # 3007566237201010562. The neurostimulator (ins) came up with the end of service message after being implanted for only a few weeks. This was the second time of it happening within a couple months. The impedance measurements were out of range: some high and low readings. The pt did experience clinical benefit from the ins before it switched off. Additional info has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1940606


« Last Edit: November 25, 2013, 08:46:51 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #32 on: November 05, 2013, 10:45:40 PM »

Model Number IPGNEURO
Device Problem Unknown (for use when the device problem is not known)
Event Date 07/26/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. At this time, no additional information was available, additional information has been requested.
 
Event Description

Literature: ackermans l, duits a, temel y, et al. Long-term outcome of thalamic deep brain stimulation in two patients with tourette syndrome. J neurol neurosurg psychiatry. Oct 2010; 81 (10): 1068-1072. Summary: the authors conducted a follow-up study to report on the long-term (6 and 10 years) outcome in terms of tic reduction, cognition, mood and side effects of medial thalamic deep brain stimulation in two previously described tourette patients. Reportable event: in patient 2, ((b)(6) male), the tic improvement at 8 months was slightly decreased at 6 years; compulsions had disappeared. This patient showed a decrease in verbal fluency and learning, a slight decrease in depression but overall psychopathology was still high at 6 years with an increase in anger and aggression together with difficulties in social adaptation. This patient reported a reduction in energy when the current intensity reached the level necessary for an optimal effect on tics; this patient did not adjust stimulation settings and preferred the feeling of drowsiness above his tics. This patient did experience a hardware-related complication consisting of traction of the lead in the neck. Multiple revisions of the wound and local injections were carried out with partial effect. This patient received seven replacements in 6 years due to his high-voltage stimulation. This patient experienced substantial improvement in sexual functioning at 8 months after surgery, but a slight decrease at the long-term follow-up except for sexual drive that increased to the maximum level. This patient experienced difficulty with his visual adaptation and vertigo, but neither of these complaints interfered with his daily life. Examination by an ophthalmologist did not reveal any disabilities. The adverse events experiences were not considered distressing at long term follow-up. See literature article with mfr report# 3007566237-2010-1064945.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1943662

« Last Edit: November 25, 2013, 08:51:19 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #33 on: November 05, 2013, 10:46:45 PM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 01/01/2010
Event Type  Injury   Patient Outcome  Other
Event Description

The hcp noted an area of hypodensity in a pt treated with deep brain stimulation. He was in the process of evaluating the event as a possible stroke. Additional info has been requested. A follow-up report will be submitted if additional info becomes available.
 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1946759
« Last Edit: November 25, 2013, 08:51:46 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #34 on: November 05, 2013, 10:47:10 PM »

Model Number IPGNEURO
Device Problem Unknown (for use when the device problem is not known)
Event Date 04/21/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: johansen kk, jorgensen jv, white lr, farrer mj, aasly jo. Parkinson-related genetics in pts treated with deep brain stimulation. Acta neurol scand. Mar 2011; 123(3): 201-206. Summary: the authors analyzed the frequency of mutations associated with parkinson's disease (pd) in a general pd population compared to pts with pd selected for deep brain stimulation (dbs) and evaluated the outcome of surgery. A total of 630 consecutive pts with pd were followed since 1998 and genetically screened, and 60 had dbs surgery between 2001 and 2009, 37 subthalamic nucleus (stn) , 21 ventro-intermediate nucleus of thalamus (vim), and two globus pallidus internus (gpi). The authors reported that all pts in both groups reported a considerable improvement of dyskinesias and painful dystonias. Reportable events: the complication rate was low with no mortality or hemorrhages. It was reported that one pt had a minor complication related to surgery; the pt experienced acute chest pain, probably attributed to cardiac ischemia and the dbs procedure was discontinued prior to implanting the electrodes. Two months later, the pt was operated for unilateral vim-dbs. One pt had a minor complication related to surgery; the pt experienced discomfort caused by tight dbs wires in the neck region and was re-operated after 7 months. There were no infections related to lead implantation, but two cases developed a mild local infection following a change of battery 5 years after dbs implantation. There were several transient neurological side effects; apraxia of eyelid opening (n=2), anxiety and depression (n=3) and hypomania (n=3). There were 4 cases of permanent cognitive impairment.
 
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. It is also possible several events occurred in one pt. At this time, no additional information was available, additional information regarding the pt, event, interventions and outcome has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2069285


« Last Edit: December 04, 2013, 07:11:46 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #35 on: November 05, 2013, 10:47:32 PM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 12/24/2010
Event Type  Death   Patient Outcome  Other,Death,Hospitalization
Event Description

Literature: sutcliffe aj, mitchell rd, gan yc, mocroft ap, nightingale p. General anaesthesia for deep brain stimulator electrode insertion in parkinson's disease. Acta neurochir (wien). Mar 2011;153(3):621-627. Summary: the authors compare the use of general and local anesthetic in patients having deep brain stimulator (dbs) surgery. This was a retrospective case note study of 46 patients treated consecutively with subthalamic nucleus stimulation for parkinson's disease as practice changed in a neurosurgical unit. The first 20 patients (la group) had permanent electrodes placed in the subthalamic nucleus under local anesthesia between (b)(6) 1999 and (b)(6) 2002. The remaining 26 patients (ga group) had the entire procedure under general anesthesia from (b)(6) 2002 onwards. The groups were similar for age, sex, duration of parkinson's disease and preoperative levodopa requirement. The authors reported that in this sample set, there was no difference in the adverse effects seen in patients undergoing deep brain stimulator insertion with general anesthetic compared with local anesthetic and the use of general anesthetic did not detract from the known benefits of surgery. Reportable event: all patients were admitted on the day before surgery, differences in the length of hospital stay were a reflection of events in the peri- and postoperative period. In the la group, one patient died as a result of a hematoma that developed intraoperatively at the track site of a permanent electrode. The hematoma was caused by the first electrode but did not become apparent until the second electrode had been positioned. This patient remained in hospital for 13 days and was excluded from the results describing postoperative levodopa requirements.
 
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. At this time no additional information was available, additional information regarding the patient and event has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2071743


« Last Edit: February 04, 2014, 03:56:16 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #36 on: November 05, 2013, 10:47:55 PM »

Model Number IPGNEURO
Device Problem High impedance
Event Date 04/01/2009
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).
 
Event Description

Received information from the physician reporting high impedance issues when using the microelectrode recording with stimpilot. No further information was provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2100663

« Last Edit: December 04, 2013, 07:13:42 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #37 on: November 05, 2013, 10:48:16 PM »

Model Number IPGNEURO
Device Problem Device stops intermittently
Event Type  Malfunction  
Event Description

It was reported that "some" patients (number unknown) had reported that their neurostimulators had "turned off" during long trips in their hybrid cars. Additional information was requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2113827

« Last Edit: December 04, 2013, 07:14:07 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #38 on: November 05, 2013, 10:48:37 PM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 07/22/2009
Event Type  Injury   Patient Outcome  Other,Required Intervention
Event Description

Literature: chhabra v, sung e, mewes k, bakay ra, abosch a, gross re. Safety of magnetic resonance imaging of deep brain stimulator systems: a serial imaging and clinical retrospective study. J neurosurg. 2010;112(3):497-502. Summary: this study aimed to examine the safety of mr imaging in 64 pts who underwent staged bilateral implantations of dbs electrodes at emory university hospital between (b)(6) 1997 and (b)(6) 2006 for parkinson disease, tremor and dystonia. Each pt underwent three separate mr imaging sessions subsequent to dbs placement. The first was performed within 24 hrs after the first dbs placement, the second occurred prior to the contralateral second dbs placement which was an average of 19. 4 months later, and the third was within 24 hrs after the second dbs placement. F/u was conducted to examine adverse events related either to mr imaging or to dbs-induced injury. Reportable events: one pt experienced encephalomalacia surrounding the first dbs lead secondary to gliosis that was noted on long-term mr imaging sequences. This pattern was consistent with insertional injury. The pt had an ablative procedure performed by intentionally subjecting a dbs lead to radiofrequency currents prior to its removal. Seven pts experienced edema. The edema appeared on the mr images taken immediately after lead placement, either on the first set of mr images or the images obtained immediately after the second lead insertion, but never on the second set of images that was performed months after the first insertion. The edema surrounded the acutely implanted lead and never was seen surrounding the chronically implanted lead. It was concluded that the edema resulted solely from micro-electrode and/or dbs-induced injury. Six pts experienced focal intraparenchymal hemorrhage. This was seen either on the first or third mr imaging sessions, but never on the second. Four pts experienced intra-ventricular hemorrhage. This was seen either on the first or third mr imaging sessions, but never on the second. One pt experienced infarct that was noted 2 days after the second dbs placement and confirmed on the repeated mr imaging studies obtained 2 weeks thereafter. One pt experienced sulcal subarachnoid blood. Seven pts experienced encephalomalacia surrounding the first dbs lead secondary to gliosis that was noted on long-term mr imaging sequences. This pattern was consistent with insertional injury. Most of these cases of encephalomalacia occurred after documented intraparenchymal hemorrhage or edema on immediate mr imaging following the first or second lead placement. No events were attributed to effects of mr imaging.
 
Manufacturer Narrative

It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. It is also possible several events occurred in one pt. The pt info provided in section a is the average for all the pts. At this time no add'l info was available, add'l info regarding the pt, event, interventions and outcome has been requested. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2098703

« Last Edit: December 04, 2013, 07:16:33 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #39 on: November 05, 2013, 10:48:59 PM »

Model Number IPGNEURO
Device Problems Break; Device operates differently than expected
Event Date 08/20/2009
Event Type  Injury   Patient Outcome  Other
Event Description

Literature: cif l, vasques x, gonzalez v, et al. Long-term f/u of dyt1 dystonia patients treated by deep brain stimulation: an open-label study. Mov disord. 2010;25(3):289-299. Summary: this article aimed to observe the long term efficacy of globus pallidal deep brain stimulation (dbs) in dyt1 dystonia, and the disease progression under dbs. Twenty-six patients were divided into two groups: those with a single lead and those with a second lead implanted due to worsening of symptomology. Reportable events: one extension cable broke that was implanted in a male pt, (b)(6) at the time of initial implantation surgery. One extension cable broke that was implanted in a male pt, (b)(6) at the time of the initial implantation surgery. One implantable pulse generator (ipg) spontaneously 'dysfunctioned' after three months. The pt was female with initial implantation surgery occurring at (b)(6). One male pt, (b)(6) at the time of initial implantation surgery, developed a 'hardware' infection. One male pt, (b)(6) at the time of initial implantation, developed a 'hardware' infection.
 
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. At this time no add'l info was available, add'l info regarding the pt, event, interventions and outcome has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2098700

« Last Edit: December 04, 2013, 07:17:32 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #40 on: November 05, 2013, 10:49:19 PM »

Model Number IPGNEURO
Device Problem No Information
Event Date 05/06/2008
Event Type  Injury   Patient Outcome  Other
Event Description

Literature: nunta-aree s, sitthinamsuwan b, boonyapisit k, pisarnpong a. Sw2-year outcomes of subthalamic deep brain stimulation for idiopathic parkinson's disease. J med assoc thai. May 2010;93(5):529-540. Summary: this article studied (b)(6) clinical outcomes, changes of medication and complications following subthalamic nucleus deep brain stimulation in patients who presented with advanced parkinson's disease in (b)(6) to (b)(6) since 2004. Twenty-seven patients with (b)(6) f/u and complete data were enrolled for retrospective eval of unified parkinson's disease rating scale, and 62 patients were enrolled for study of surgical complications. Reportable events: one pt experienced wound infection. One pt experienced a stimulation induced hemiballism. One pt experienced an asymptomatic intracerebral hemorrhage.

Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. At this time no add'l info was available, add'l info regarding the pt, event, interventions and outcome has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2098701

« Last Edit: December 04, 2013, 07:18:06 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #41 on: November 05, 2013, 10:49:38 PM »

Model Number IPGNEURO
Device Problems Break; High impedance
Event Date 01/01/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4) (paresthesia). It was not possible to ascertain specific device information from the article or to match the event reported with a previously reported event. At this time, no additional information was available, additional information regarding the patient, event, interventions and outcome has been requested. This report is being submitted late due to a delay by a mfr employee. A process improvement plan and training are in place.
 
Event Description

Literature: deandrade dc, gurruchaga j-m, jarraya b, et al. Paroxysmal positive symptoms caused by hardware malfunctioning in deep brain stimulation. Brain stimul. 2010;3(1):61-62. Summary: this editorial discusses a case of hardware dysfunction as revealed by transient positive symptoms. The (b)(6) female patient with parkinson's disease underwent successful surgery for bilateral subthalamic nucleus stimulation. Reportable event: after one year of symptom control, the patient presented to the emergency room with horizontal diplopia and sudden onset of intermittent paresthesia on the left hand. Turning the head to the right could trigger the symptoms most of the time. Impedance measurements on the right side were greater than 4000 ohms. The stimulation was decreased resulting in partial control of parkinsonian symptoms with resolution of the diplopia and paresthesia. No disconnections or breakages were seen on ct scan or radiographic study. An electrode test was performed one week later. Stimulation of both lower electrodes triggered the symptoms, and impedance and current on one of the electrodes spontaneously changed from greater than 4000 ohms and less than 15 micro amps to 955 ohms and 28 micro amps on two consecutive measures on the same week. A surgical revision of the system was performed during which a breakage proximal to the connection of the dbs lead with the extension was found. The plastic protection was intact, but the wire inside was disconnected. The lead was replaced and the patient regained symptomatic relief after a couple of weeks.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2107175


« Last Edit: December 04, 2013, 07:19:15 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #42 on: November 05, 2013, 10:50:00 PM »

Model Number IPGNEURO
Device Problem Device operates differently than expected
Event Date 11/02/2009
Event Type  Injury   Patient Outcome  Other
Event Description

Literature: romito lm, contarino fm, albanese a. Transient gender-related effects in parkinson's disease pts with subthalamic stimulation. J neurol. Apr 2010;257(4):603-608. Summary: this study assessed the possible gender differences in clinical outcome and disease progression along a 5-year period after subthalamic nucleus deep brain stimulation (stn-dbs) for parkinson's disease. Clinical outcome, disease progression and adverse events were assessed at baseline and 1, 3, and 5 years after surgery. The first 20 consecutive pd pts who received bilateral implant for stn stimulation and reached the 5-year period were f/u (11 men, 9 women) were included in the study. Dopamine agonists were withdrawn one week before surgery and levodopa the evening before. Medication was gradually introduced after implant just to the dose necessary to permit optimal motor control in addition to stimulation. Each post-operative test session used three unified parkinson's disease rating scale evaluations and looked at medication off/stimulation off, medication off/stimulation on, and medication on/stimulation on conditions. Adverse events were classified as transient, persistent (if not improved by turning off stimulation for a short time), stimulation-induced (present at optimal stimulation parameters, but improved when stimulation was turned off or parameters were modified), device-related, or unrelated to the procedure or stimulation. Reportable events: one male pt experienced unexplained switching off of the dbs. One female pt experienced unexplained switching off of the dbs. One male pt experienced cable dehiscence due to infection. One male pt experienced transient seizures responsive to antiepileptic drugs.
 
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. It is also possible several events occurred in one pt. At this time no additional info was available, additional info regarding the pt, event, interventions and outcome has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2107262
« Last Edit: December 04, 2013, 07:20:32 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #43 on: November 05, 2013, 10:50:22 PM »

Model Number IPGNEURO
Device Problem Device operates differently than expected
Event Type  Malfunction  
Event Description

It was reported that a stimloc clip didn't engage. Additional information was requested.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2107388
« Last Edit: February 04, 2014, 04:05:54 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #44 on: November 05, 2013, 10:51:03 PM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 06/24/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. It is also possible several events occurred in one pt. At this time no additional information was available, additional information has been requested.
 
Event Description

Literature: hu x, jiang x, zhou x, et al. Avoidance and management of surgical and hardware-related complications of deep brain stimulation. Stereotact funct neurosurg. 2010;88(5):296-303. Summary: the authors performed a retrospective analysis of patients who received dbs over a 9-year period from march 2000 to december 2008. This study included 161 patients (85 male and 76 female). Of them, 153 patients suffered from idiopathic parkinson disease, 2 from essential tremor, and 6 from dystonia. The patients ranged in age from 16 to 80 years with a mean of 63. 5 8 8. 7 years. Intraoperative and postoperative antibiotics were administered for 3-5 days. Preventive anticonvulsant treatment was initiated 3-5 days before surgery and discontinued 2-3 weeks after surgery. Postoperative ct scan was performed in all patients within 24 hrs after electrode implantation. All patients were clinically followed up for 6-84 months (mean 14 month). Reportable event: skin erosion occurred in a (b)(6) boy who presented with primary dystonia. He underwent bilateral dbs targeting stn with simultaneous ipg implantation. Five months later, signs of skin erosion were noticed at the right bottom of the ipg location. The ipg was removed under local anesthesia, with the electrode-extension wire preserved. Three months later, the ethylene-oxide-sterilized original ipg was implanted subcutaneously into the contralateral (left) chest.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1907196
« Last Edit: December 04, 2013, 07:21:42 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #45 on: November 05, 2013, 10:51:27 PM »

Model Number IPGNEURO
Device Problem Migration of device or device component
Event Date 09/01/2010
Event Type  Injury   Patient Outcome  Hospitalization,Life Threatening,Required Intervention
Manufacturer Narrative

(b)(4). It is not possible to ascertain specific device info from the article or to match the events reported with previously reported events. At this time no additional info was available, additional info has been requested.
 
Event Description

Literature: hyam ja, de pennington n, joint c, et al. Maintained deep brain stimulation for severe dystonia despite infection by using externalized electrodes and an extracorporeal pulse generator. J neurosurg. Sep 2010;113(3):630-633. Summary: the authors present two cases of severe dystonia in which deep brain stimulation was maintained despite the presence of infection at the site of the pulse generator, using ongoing stimulation by externalization of electrode wires and an extracorporeal pulse generator. This allowed the infection to clear and wounds to heal while maintaining stimulation. Reportable event: a (b)(6) girl with a 6-year history of medically intractable generalized tonic dystonia (dyt1 negative) underwent bilateral implantation of deep brain electrodes in the globus pallidus internus. Six months after the procedure, there was a 65% decrease in her bfmdrs score. This marked improvement gave her the ability to play independently for the first time, but 10 months after surgery she dislodged one of her electrodes while testing this freedom by sliding down a staircase on her abdomen. Her symptoms worsened, and her displaced electrode was revised. Following revision she developed a spreading infection from the abdominal would that failed to respond to broad-spectrum intravenous antibiotics. She developed signs of systemic sepsis, and the entire dbs system was removed. The sudden loss of stimulation precipitated a dystonic crisis, which compromised her respiratory function and necessitated emergency intubation and ventilation for 21 days. To allow wearing of ventilatory support, a dbs system was implanted despite the likely continued presence of infection. Over the next 6 years she underwent 11 further procedures to replace her pulse generators and deal with recurrent wound infections. Multiple wound swabs were taken but only one exhibited positive growth, a methicillin-sensitive staphylococcus aureus. Throughout most of this time, the pt received oral rifampicin and several courses of intravenous antibiotics. Dermatological skin patch testing was negative for sensitivity to pulse generator components. Although she remained systemically well, her dystonia deteriorated. Her entire system was revised 6 years after her original surgery, and the extension cables tunnelled along new paths to a new pulse generator implanted deep to the rectus abdominis muscle. Unfortunately after 6 months, the abdominal wound dehisced again. The authors believed that her recurrent wound problems were due to chronic hardware-related infection, and therefore, they externalized her existing pulse generator to the now extracorporeal, resterilized pulse generator. The pulse generator remained externalized for 4 months within an improvised carrying pouch; once all wounds were healed; new extension leads were tunnelled from the head to a new pulse generator placed in a new subpectoral wound. All antibiotics had been stopped for 18 months, inflammatory markers were normal, and all wounds had healed well. The pt's dystonia has improved again to the level initially achieved following her first surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1907359


« Last Edit: December 04, 2013, 07:24:46 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #46 on: November 05, 2013, 10:51:50 PM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 06/24/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: hu x, jiang x, zhou x, et al. Avoidance and management of surgical and hardware-related complications of deep brain stimulation. Stereotact funct neurosurg. 2010; 88(5): 296-303. Summary: the authors performed a retrospective analysis of patients who received dbs over a 9-year period from march 2000 to december 2008. This study included 161 patients (85 male and 76 female). Of them, 153 patients suffered from idiopathic parkinson disease, 2 from essential tremor, and 6 from dystonia. The patients ranged in age from 16 to 80 years with a mean of 63. 5 8 8. 7 years. Intraoperative and postoperative antibiotics were administered for 3-5 days. Preventive anticonvulsant treatment was initiated 3-5 days before surgery and discontinued 2-3 weeks after surgery. Postoperative ct scan was performed in all patients within 24 h after electrode implantation. All patients were clinically followed up for 6-84 months (mean 14 months). Reportable event: there were 3 patients who experienced formation of seroma around the ipg location, in whom subcutaneous bloody fluid was drained 3-5 days after surgery. They were cured after puncture drainage.
 
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. The patient information provided in section a is the average for all the patients. At this time no additional information was available, additional information has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1907203

« Last Edit: February 04, 2014, 04:06:55 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #47 on: November 05, 2013, 10:52:15 PM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 06/24/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: hu x, jiang x, zhou x, et al. Avoidance and management of surgical and hardware-related complications of deep brain stimulation. Stereotact funct neurosurg. 2010;88(5):296-303. Summary: the authors performed a retrospective analysis of patients who received dbs over a 9-year period from march 2000 to december 2008. This study included 161 patients (85 male and 76 female). Of them, 153 patients suffered from idiopathic parkinson disease, 2 from essential tremor, and 6 from dystonia. The patients ranged in age from 16 to 80 years with a mean of 63. 5 8 8. 7 years. Intraoperative and postoperative antibiotics were administered for 3-5 days. Preventive anticonvulsant treatment was initiated 3-5 days before surgery and discontinued 2-3 weeks after surgery. Postoperative ct scan was performed in all patients within 24 hrs after electrode implantation. All patients were clinically followed up for 6-84 months (mean 14 month). Reportable event: there were 3 patients who experienced formation of seroma around the ipg location; the seroma was cerebrospinal fluid leaking through the burr hole ring and cap along the electrode-extension wire to the chest where the ipg was located. After bandaging the patient's head with pressure, the subcutaneous fluid was stopped.
 
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. The patient information provided in section a is the average for all the patients. At this time no additional information was available, additional information has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1907204

« Last Edit: February 04, 2014, 04:07:23 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #48 on: November 05, 2013, 10:52:51 PM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 04/01/2010
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative

(b)(4). At this time, no additional information was available. Additional information has been requested.
 
Event Description

Literature: vergani f, landi a, pirillo d, cilia r, antonini a, sganzerla ep. Surgical, medical, and hardware adverse events in a series of 141 patients undergoing subthalamic deep brain stimulation for parkinson disease. World neurosurg. Apr 2010;73(4):338-344. Summary: the authors reported a single center, retrospective analysis of complications in a large population of parkinsonian patients with a long-term follow-up (mean, 4. 6 years). A total of 141 patients underwent bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) between (b)(6) 1998 and (b)(6) 2007. In this series, neither seizures nor extradural/subdural hematomas were observed. Reportable event: one patient presented with an inflammatory seroma at the ipg level that was treated with repeated percutaneous tapping. The aspirate from the seroma was sterile after microbiology analysis. This complication required a longer in-hospital stay for the patient. See literature article with mfr report# 3007566237201008991.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1895220

« Last Edit: February 04, 2014, 04:08:15 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #49 on: November 05, 2013, 10:53:14 PM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 04/01/2010
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description

Literature: vergani f, landi a, pirillo d, cilia r, antonini a, sganzerla ep. Surgical, medical, and hardware adverse events in a series of 141 patients undergoing subthalamic deep brain stimulation for parkinson disease. World neurosurg. Apr 2010;73(4):338-344. Summary: the authors reported a single center, retrospective analysis of complications in a large population of parkinsonian patients with a long-term follow-up (mean, 4. 6 years). A total of 141 patients underwent bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) between (b)(6) 1998 and (b)(6) 2007. In this series, neither seizures nor extradural/subdural hematomas were observed. Reportable event: one patient presented 1 week after surgery with a cerebrospinal fluid leakage at the calvarium that resolved after compressive dressing of the wound. Antibiotic prophylaxis with cefazolin was also administered. This complication required a longer in-hospital stay for the patient.
 
Manufacturer Narrative

(b)(4). At this time no additional information was available, additional information has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1895242
« Last Edit: February 04, 2014, 04:08:40 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #50 on: November 05, 2013, 10:53:36 PM »

Model Number IPGNEURO
Device Problem Malposition of device
Event Date 04/01/2010
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description

Literature: vergani f, landi a, pirillo d, cilia r, antonini a, sganzerla ep. Surgical, medical, and hardware adverse events in a series of 141 patients undergoing subthalamic deep brain stimulation for parkinson disease. World neurosurg. Apr 2010;73(4):338-344. Summary: the authors reported a single center, retrospective analysis of complications in a large population of parkinsonian patients with a long-term follow-up (mean, 4. 6 years). A total of 141 patients underwent bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) between (b)(6) 1998 and (b)(6) 2007. In this series, neither seizures nor extradural/subdural hematomas were observed. Reportable event: one patient experienced a malpositioning of the left subthalamic electrode resulted in a suboptimal control of parkinsonian motor signs on the right side. A second operation was carried out to replace the electrode, obtaining a successful reprise of stn dbs. This complication required a longer in-hospital stay for the patient.
 
Manufacturer Narrative

(b)(4). At this time, no additional information was available, additional information has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1895244

« Last Edit: February 04, 2014, 04:09:38 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #51 on: November 05, 2013, 10:54:00 PM »

Model Number IPGNEURO
Device Problem Improper or incorrect procedure or method
Event Date 01/01/2010
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).
 
Event Description

On (b)(6) 2010, it was initially reported that the proximal end of a lead was damaged during a stage 2 procedure. The physician cut off the last contact of the lead. The physician retained the existing lead. Patient programming was planned. On (b)(6) 2010, it was further reported that the physician had made an incision behind the patient's ear to expose the leads. The physician had trouble removing one of the temporary lead covers of the third contact. The set screw was found to be too tight and the physician could not get the screw to release. The physician then dissected the temporary lead housing, and the set screw did come off, however, the bottom contact was destroyed in the process. The entire contact came off, so the bottom contact was cut off. A company representative tested impedance, and all measurements came back normal even with the contact missing. It could not be recalled which side the contact was cut from. Stimulation was not 'pushed high enough' for the company representative to determine which side the contact was missing from (left or right). No device component was explanted. The patient was fine, however, the company representative did not consider the patient to be fully recovered due to the faulty lead. Additional information will be provided in a follow-up report as it becomes available.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1899777
« Last Edit: February 04, 2014, 04:10:31 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #52 on: November 05, 2013, 10:54:23 PM »

Model Number IPGNEURO
Device Problem Fracture
Event Date 10/14/2010
Event Type  Malfunction  
Event Description

During the tunneling between the adapter and the implantable neuro stimulator, an obturator was inserted into the tunneling tool. The obturator broke inside the tool. The surgeon replaced the tunneling tool with a new one, and completed the implant procedure. It was noted that there was no health hazard to the pt.
 
Manufacturer Narrative

(b)(4). Analysis results were not available at the time of this report. A f/u report will be sent when analysis is completed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1898556
« Last Edit: February 04, 2014, 04:11:00 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #53 on: November 05, 2013, 10:54:43 PM »

Model Number IPGNEURO
Device Problems Fracture; Device Issue; Positioning Issue
Event Date 08/01/2010
Event Type  Death   Patient Outcome  Death,Required Intervention
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. It is also possible several events occurred in one pt. The pt info provided in section a is the average for all the pts. At this time, no add'l info was available, add'l info has been requested.
 
Event Description

Literature: burdick ap, fernandez hh, okun ms, chi yy, jacobson c, foote kd. Relationship between higher rates of adverse events in deep brain stimulation using standardized prospective recording and pt outcomes. Neurosurg focus. Aug 2010;29(2):e4. Summary: the authors disclose the standardized and prospectively recorded ae data from their institution between (b)(6) 2002 and (b)(6) 2008. Two hundred seventy dbs procedures were performed in 198 pts; 26 pts had dystonia, 43 had essential tremor, 113 had parkinson disease, 6 had ocd, and 10 had other causes of tremor. The dbs leads were implanted on the left hemisphere in 133 procedures, on the right in 88, and bilaterally in 49. A total of 300 aes were recorded in 146 of the 270 procedures, and the aes were recorded in 119 of 198 pts. No significant qol differences. Event: the frequency of the 300 adverse events were as follows: mental status decline 53, other (unspecified) 43, gait problem 21, other motor problem 20, seizure 16, ich (symptomatic) 16, lead misplacement 15, speech-aphasia 13, speech-dysarthria 11, subdural/other bleed 11, mania/hypomania 8, infection, deep (hardware removal) 7, air embolus 6, speech-hypophonia 6, depression 6, infection, deep (revision, iv antibiotics) 5, swallow problem 5, anxiety 5, incontinence 4, visual problem 4, infection, superficial (oral antibiotics) 4, hardware malfunction (other) 4, death 2, hardware malfunction (fracture) 2, hydrocephalus 2, neurological deficit (other) 2, stroke 2, scalp erosion 2, suicidal ideation 2, ipg seroma 1, other sensory problem 1 and psychogenic disorder 1. See attached literature article.
 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1885229
« Last Edit: February 04, 2014, 04:14:10 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #54 on: November 05, 2013, 10:55:08 PM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 07/08/2010
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative

(b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. It is also possible, several events occurred in one patient. At this time, no additional information was available, additional information has been requested.
 
Event Description

Literature: gruber d, kuhn aa, shoenecker t, et al. Pallidal and thalamic deep brain stimulation in myoclonus-dystonia. Mov disord. Aug 15 2010; 25(11):1733-1743. Summary: the authors investigated short- and long term effects on motor function, cognition, affective state, and quality of life (qol) of gpi- and vim-dbs in myoclonus-dystonia (md). Ten md patients were evaluated pre- and post-surgery between 1997 and 2009. Both gpi- and vim-dbs are effective. There were fewer adverse, stimulation induced events with gpi-dbs in comparison with vim-dbs. There were 18 reversible stimulation-dependent adverse events (ae) in the vim group which resolved by adaptation of parameters; these include dysarthria, dysphagia, dysgeusia, worsening dystonia, headache, gait disturbance, dysaesthesias. There were 4 events experienced by the gpi group; these were nausea and phosphene. It was unclear which patients experienced which adverse event; however, no serious long-lasting stimulation-related ae's were observed. Reportable event: patient 8 of 10 received bilateral gpi and vim-electrodes; this patient experienced a reversible intracerebral hemorrhage less than or equal to 3 month's hemiparesis. The source literature did not specify which device models were used for the different patients. See literature article with mfr report# 3007566237201007967.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1872749

« Last Edit: February 04, 2014, 04:15:35 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #55 on: November 05, 2013, 10:55:31 PM »

odel Number IPGNEURO
Device Problem Break
Event Date 08/09/2010
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). This report is being submitted late due to a delay by a mfr employee. A process improvement plan and training are in place.
 
Event Description

It was reported that the carrier of the tunneling kit snapped when the extension leads were being passed through the pt. The "carrier socket part (plastic)" of the carrier got caught internally and broke. The same extension lead was used and no harm was caused to the pt. Additional info has been requested, a f/u will be sent if additional info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1861118


« Last Edit: February 04, 2014, 04:16:01 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #56 on: November 05, 2013, 10:55:55 PM »

Model Number IPGNEURO
Device Problem No Information
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

It was reported that during implantation of the lead, the pt developed intraventricular bleeding. The physician attempted to place a shunt but that produced more bleeding. It was noted that the pt was taking multiple over-the-counter herbs. The pt's outcome was reported as okay. Additional information was requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1822584


« Last Edit: February 04, 2014, 04:16:38 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #57 on: November 05, 2013, 10:56:19 PM »

Model Number IPGNEURO
Device Problem Device stops intermittently
Event Date 04/01/2010
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Reason for late mdr due to implementation of process improvement.
 
Event Description

It was reported the pt's neurostimulator was shutting off and turning on by itself. This issue with the neurostimulator arose while the pt was in the hospital recovering from knee replacement surgery from the "past week". Prior to the surgery the pt did not have this problem. A follow-up report will be sent if additional info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1845993

« Last Edit: February 04, 2014, 04:17:10 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #58 on: November 05, 2013, 10:56:40 PM »

Model Number IPGNEURO
Device Problem No Information
Event Date 01/01/1984
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

It was reported that the patient had a deep brain stimulator (dbs) implanted in 1983. One year later, the "hardware" failed and "everything was removed except the electrode in the brain. " the week following mother's day 2010, the patient had a petit mal seizure. The patient had "several" additional seizures since that time. No further details, patient symptoms or outcome were provided at the time of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1824554

« Last Edit: February 04, 2014, 04:17:39 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55415


« Reply #59 on: November 05, 2013, 10:57:01 PM »

Model Number UNKNOWN
Device Problems Fracture; Device or device fragments location unknown
Event Date 04/01/2010
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative

(b) (4).
 
Event Description

It was reported that the distal end of the carrier broke off into the pt's neck area when the extension was being pulled through. The doctor tried to locate the piece of carrier and remove it, but couldn't locate it. It was suggested that fluoroscopy be performed to see if the carrier piece could be located, but the doctor did not want to use fluoroscopy and decided to leave the piece of carrier inside the pt's body.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1674885
« Last Edit: February 04, 2014, 04:18:01 AM by dennis100 » Logged
Pages: 1 [2] 3 4 ... 11   Go Up
Print
Jump to: