Pages: [1] 2 3 ... 10
 1 
 on: September 21, 2018, 02:09:27 PM 
Started by dennis100 - Last post by dennis100
Model Number 102R
Event Date 12/14/2011
Event Type  Injury   
Event Description
It was reported that the patient was admitted to the hospital due to pain in the shoulder and neck that the physician and family attributes to vns. The vns was turned off and the pain seemed to stop once vns is off. Per physician, the pain begins once the vns stimulates, but lasts a little longer than the 30 second on time. The physician later decided to turn the vns back on to 0. 25 ma and the patient said this was more 'tolerable'. The patient then underwent generator replacement surgery as the generator had been implanted for some time. During surgery, the surgeon noted that upon removing the lead pins, the positive pin wasn't flush; and didn't appear fully inserted. Also, clear fluid came out of the generator receptacle when the positive pin was completely removed. It was also noted that the pin did not appear fully inserted in the x-rays, per surgeon. However, pre-operative diagnostics were within normal limits.
 
Event Description
Further information reveals that no patient manipulation or trauma occurred that is believed to have caused or contributed to the painful stimulation. No causal or contributory programming or medication changes preceded the onset of the painful stimulation. The only intervention taken was the generator replacement and the physician indicated that the pain has resolved since the generator replacement surgery. Attempts for product return have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2414487

 2 
 on: September 21, 2018, 02:08:35 PM 
Started by dennis100 - Last post by dennis100
Model Number 102
Event Date 12/20/2011
Event Type  Injury   
Event Description
On (b)(6) 2011 a vns implanting surgeon reported that the vns patient wants his device explanted due to painful stimulation in his chest just above the generator. The patient is not currently seeing a psychiatrist for his vns and consulted directly with the surgeon for the removal of his vns. The surgeon does not know when the pain first started and was not able to provide any further information. A battery life calculation was performed with the programming history available which revealed 2. 9 years until the elective replacement indicator (eri) shows yes. The explant surgery took place on (b)(6) 2011 and the explanted lead and generator were returned for product analysis on (b)(6) 2012 that has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2413731

 3 
 on: September 21, 2018, 02:07:20 PM 
Started by dennis100 - Last post by dennis100
Model Number 102
Event Date 07/25/2011
Event Type  Injury   
Event Description
Additional information was received from the patient's treating neurologist indicating that the patient's device was initially programmed off in 2008 due to painful stimulation. In (b)(6) 2011, the patient first reported feeling the vns stimulate, despite being turned off. When the device was interrogated it was determined that the magnet had been left on to 1. 5ma, but diagnostics were within normal limits. The magnet mode current was disabled that day. There were no causal or contributory programming or medication changes that preceded the onset of the event. Manipulation and trauma were also no suspected. The physician indicated that the patient was still experiencing these sensations when the device was programmed off, but when the magnet was taped over the device, it helped. The patient did not experience these issues pre-vns.
 
Event Description
Review of available programming history revealed that the patient was disabled on (b)(6) 2007. It is unclear from the available history if the patient was re-enabled after that date.
 
Event Description
Additional information was received that the patient had a generator and lead replacement. Product analysis was completed on the lead and still is in process for the generator. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.
 
Event Description
It was reported through clinic notes received on (b)(6) 2011 that the patient was experiencing a choking sensation when she eats and trouble breathing and pain across her chest when the device stimulates. The patient indicated that she has this sensation about once a week. The patient is being scheduled for replacement because of this. The physician indicated; however that the device output and magnet mode currents are presently set to 0. 0ma. The physician indicated that the patient needed the device removed regardless of whether it was stimulating or just causing irritation. Explant is likely; however has not occurred to date.
 
Manufacturer Narrative

Event Description
Product analysis was completed on the generator. Although the negative septum appears to be split, there is no evidence of dried body fluids, corrosion in the connector block and there is no evidence of dried body fluids in the lead cavity, thus eliminating the possibility of a potential unintended electrical current path through body fluids. Analysis in the pa lab determined that the generator had reached an end of service condition; an open can measurement of the battery voltage confirmed that the battery was depleted. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2414917

 4 
 on: September 21, 2018, 02:05:00 PM 
Started by dennis100 - Last post by dennis100
Event Type  Injury   
Event Description
The abstract of the article ¿vagus nerve stimulation therapy in epilepsy patients. Long-term outcome and adverse effects: a retrospective analysis¿ was received and reviewed by the manufacturer. Please see abstract below: ¿background: vagus nerve stimulation (vns) is one of the numerous stimulation procedures used in the treatment of neurological diseases in which there has been growing interest in recent years. Since 1988 it has been frequently used in the therapy of epilepsies but the mechanism of action is still unknown. It is considered to be low in adverse effects. Topics: decision-making process on vns therapy as well as long-term outcome and adverse effects. Method: retrospective analysis of all 62 patients treated over a long period by vns in the epilepsy center of the university hospital of freiburg (germany) from (b)(6) 2002 through (b)(6) 2011. Results: outcome: the results show that 2 out of 62 patients became seizure-free under vns therapy while maintaining the already existing anti-ictal medication and 4 more patients under vns plus dosage increase of the already existing medication and/or new medication. However, in 34 out of 62 patients vns therapy did not improve the seizure situation. Adverse effects: vns is not as low in adverse effects as is generally considered. Only 9 out of 62 patients did not show any adverse effects and on the other hand severe, even life-threatening adverse effects also occurred. Conclusion: patients undergoing vns therapy have to be carefully checked for possible adverse effects, not only at the beginning of vns therapy but also in the long-term course. These results have to be considered in the cost-benefit analysis of this treatment. ¿ the article, written in german, was later received by the manufacturer. Per the article, thirteen patients experienced adverse events related to the vns surgery or vns. A translation of the chart with patient information and outcomes revealed the following adverse events were observed: necrosis, increase in seizures (that were possibly psychogenic), wound infections, secondary rupture of sutures, recurrent laryngeal nerve paresis, horner¿s syndrome, wound dehiscence, lead break, and asystole. The following manufacturer report numbers are associated with each patient and their respective events: mfr #: 1644487-2014-00031 -- asystole, associated with vns. Mfr #: 1644487-2014-00032 -- recurrent laryngeal nerve paresis associated with complications from surgery. Mfr #: 1644487-2014-00033 -- increase in seizures, which were possibly psychogenic, related to vns. Mfr #: 1644487-2014-00034 -- secondary rupture of sutures, associated with complications from surgery, and dysesthesia with the vns. Mfr #: 1644487-2014-00035 -- wound infection associated with complications from surgery, and psychotic episodes associated with vns. Mfr #: 1644487-2014-00036 -- recurrent laryngeal nerve paresis and horner¿s syndrome associated with complications from surgery. Mfr #: 1644487-2014-00037 -- lead break. Mfr #: 1644487-2014-00038 -- recurrent laryngeal nerve paresis, lead pulling sensation, and lead break associated with complications from surgery. Mfr #: 1644487-2014-00039 -- wound infection and secondary rupture of sutures associated with complications from surgery. Mfr #: 1644487-2014-00040 -- necrosis, associated with complications from surgery. Mfr #: 1644487-2014-00041 -- wound dehiscence associated with complications from surgery. Mfr #: 1644487-2014-00042 -- wound dehiscence associated with complications from surgery. Mfr #: 1644487-2014-00043 -- necrosis, lead pulling sensation, and lead break associated with complications from surgery.
 
Manufacturer Narrative
Date of birth, corrected data: initial mdr inadvertently provided the incorrect information. Sex, corrected data: initial mdr inadvertently stated this information was unknown; however, the information was known at the time. If implanted, corrected data: initial mdr inadvertently provided the incorrect information. Describe event or problem, corrected data: the initial mdr inadvertently referenced the related mfr numbers incorrectly. The following manufacturer report numbers are associated with each patient¿s respective events reported in the article: mfr #: 1644487-2014-00031 -- asystole related to vns. Mfr #: 1644487-2014-00032 -- recurrent laryngeal nerve paresis associated with complications from surgery and psychotic episodes associated with vns. Mfr #: 1644487-2014-00033 -- increase in seizures, which were possibly psychogenic, related to vns. Mfr #: 1644487-2014-00034 -- secondary rupture of sutures, associated with complications from surgery, and dysesthesia with the vns. Mfr #: 1644487-2014-00035 -- wound infection associated with complications from surgery, and psychotic episodes associated with vns. Mfr #: 1644487-2014-00036 -- recurrent laryngeal nerve paresis and horner¿s syndrome associated with complications from surgery. Mfr #: 1644487-2014-00037 ¿ lead break. Mfr #: 1644487-2014-00038 -- recurrent laryngeal nerve paresis, lead pulling sensation, and lead break associated with complications from surgery. Mfr #: 1644487-2014-00039 -- necrosis, associated with complications from surgery. Mfr #: 1644487-2014-00040 -- wound infection and secondary rupture of sutures associated with complications from surgery. Mfr #: 1644487-2014-00041 -- wound dehiscence associated with complications from surgery. Mfr #: 1644487-2014-00042 -- wound dehiscence associated with complications from surgery. Mfr #: 1644487-2014-00043 -- necrosis, lead pulling sensation, and lead break associated with complications from surgery.
 
Manufacturer Narrative

Event Description
Follow up with the physician was performed. The physician stated that he had reported these events to the manufacturer in time and he was not willing to support any further dialog regarding these issues. The physician confirmed that there were no critical situations around the vns and that in cases where vns was critical, the device had been disabled and/or explanted. No additional information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3549167

 5 
 on: September 21, 2018, 02:04:08 PM 
Started by dennis100 - Last post by dennis100
Event Date 01/01/1999
Event Type  Malfunction   
Manufacturer Narrative
Article citation: (b)(4).
 
Event Description
During manufacturer review of the published article (b)(4), it was identified that a patient had a vns generator that was still stimulating with magnet activation after the magnet mode had been disabled. The patient also had painful stimulation with the vns, along with severe painful dysesthesia in the left mandibular and cervical region. Replacement of the vns generator resolved the events. The time of the event is unknown, as the article was a retrospective review from 1999 through 2008. Attempts to the author for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2360570

 6 
 on: September 21, 2018, 02:02:28 PM 
Started by dennis100 - Last post by dennis100
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/02/2015
Event Type  Death   
Event Description
It was reported that the vns patient passed away. The funeral home indicated that the device was explanted by the medical examiner and would be returned for analysis. The medical examiner's office indicated that the autopsy is pending, but would be provided when completed. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date. No additional relevant information has been received to date.
 
Manufacturer Narrative

Event Description
The autopsy finding were listed as clinical history of rett syndrome with a history of uncontrolled seizures, musculature atrophy of extremities, scoliosis; pulmonary congestion/edema; history that the decedent was found unresponsive in a prone position in bed. The conclusion was noted to be that the decedent died as a result of a seizure disorder associated with rett syndrome. The manner of death was listed as natural.
 
Event Description
Analysis of the generator was completed on (b)(6) 2015. The module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead was completed on (b)(6) 2015. Note that the majority of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, zirconium, aluminum, sulphur and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4772129

 7 
 on: September 21, 2018, 02:01:35 PM 
Started by dennis100 - Last post by dennis100
Model Number 104
Event Date 09/18/2011
Event Type  Death   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
An obituary search on (b)(6) 2013 showed that this vns patient had passed away on (b)(6) 2011. The patient had been lost to follow-up, and the most recent physician did not know the patient¿s whereabouts. Follow-up with the funeral home showed that the location of the patient¿s device was unknown: it was unknown if the patient was buried with the device. Review of programming history showed that the patient¿s device was still programmed on as of (b)(6) 2011.
 
Event Description
It was reported that an autopsy was performed so the vns system was most likely removed during the autopsy. The death certificate indicated that the patient died in the emergency department. The immediate cause of death is listed as chronic seizure disorder complicated by drowning. The manner of death was listed as accident and the injury was described as seizure in bathtub. The coroner indicated that he is certain the device was explanted; however, the facility indicated that they were unable to locate the device. The autopsy report did not list that the vns was explanted. The autopsy reported indicated that there was aspirated foreign material in the patient's airways. The final diagnosis was chronic seizure disorder complicated by drowning, status post implantation of vagal stimulation, cutaneous immersion changes, aspiration of gastric contents, pulmonary edema, and vascular ectasia of left dorsomedial thalamus. There were no significant injuries identified. It was noted that the descendent had an extensive seizure history and was found prone in a bathtub with his face underwater by a staff member of the group care home. Hospitalization records 5-6 months prior to the patient's death showed that the patient was hospitalized from (b)(6) 2011 for physical aggression towards caregivers. The patient was experiencing auditory and visual hallucinations. The patient was discharged in stable condition. The patient was hospitalized again from (b)(6) 2011 due to agitation and abusive behavior toward the care facility staff. The patient was discarded as improved and more stable.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3548834

 8 
 on: September 21, 2018, 02:00:48 PM 
Started by dennis100 - Last post by dennis100
Model Number 103
Event Date 04/20/2011
Event Type  Death   
Event Description
It was reported that from our (b)(4) representative that there was a vns patient that died on (b)(6) 2011, 07 weeks after implantation and under vns therapy. The patient who had been implanted vns device on (b)(6) 2011, died on (b)(6) by myocardial infarction. During the explantation procedure, infection and fibrosis were not found. Additional information was received through a death follow-up form indicating that the patient was receiving therapy at the time of death and patient had an autopsy performed. The treating physician indicated that the patient's death was not related to vns. Further information from the autopsy report indicated that the cause of death was due to coagulative necrosis in the heart and pulmonary edema. The treating physician indicated that the patient's cause of death was of sudep and vns device was not related. The explanted generator was received by the manufacturer and underwent analysis. Analysis of the returned generator revealed that there were no adverse functional, mechanical, or visual issues identified with the returned generator. Analysis of the returned lead revealed that other than typical wear and explant related observations, no anomalies were identified within the returned lead portion. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2265203


 9 
 on: September 21, 2018, 01:57:49 PM 
Started by dennis100 - Last post by dennis100
Model Number 304-20
Event Date 07/10/2015
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported on (b)(6) 2015 from the patient that after his vns implantation surgery on (b)(6) 2015 he ended up with a blood clot on his neck at the surgical site. He was on blood thinners after surgery so they stopped those and he started back on warfarin. Follow-up with the neurologist showed that the patient does have a medical history of pulmonary embolism events. No interventions have been taken for the blood clot but the issue is not yet completely resolved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5024811

 10 
 on: September 21, 2018, 01:56:00 PM 
Started by dennis100 - Last post by dennis100
Model Number 304-20
Event Date 10/01/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
Date: settings [output current (ma)/ frequency (hz)/ pulse width (microseconds)/ on time (seconds)/ off time (minutes)/ magnet output current (ma)/ magnet pulse width (microseconds)/ magnet on time (seconds)]; diagnostics: [(normal mode) output status/ lead impedance; (system mode) output status/ lead impedance/ impedance value/ end of service?] : (b)(6) 2012: 0. 5/30/500/30/5; 0. 75/60/500; diagnostics: ok/ok; ok/ok/no; (b)(6) 2012: 1. 0/30/500/30/5; 1. 5/60/500; diagnostics: ok/ok; ok/ok/3200ohms/no; (b)(6) 2013: 1. 0/30/500/30/5; 1. 5/60/500; diagnostics: ok/ok; ok/ok/no; (b)(6) 2013: 1. 0/30/500/30/5; 1. 5/60/500; diagnostics: ok/ok; ok/ok/2762ohms/no; (b)(6) 2013: 1. 0/25/500/30/5; 1. 5/60/500; diagnostics: ok/ok; ok/ok/2712ohms/no; (b)(6) 2013: 1. 0/25/500/30/5; 1. 5/60/500; diagnostics: ok/ok; ok/ok/2887ohms/no; (b)(6) 2013: 1. 0/25/500/21/1. 9; 1. 5/60/500; diagnostics: ok/ok; ok/ok/2867ohms/no.
 
Event Description
It was reported that the patient was diagnosed with vocal cord problem that the ent attributes to vns therapy. It was reported that the patient experiences some difficulty breathing as a result of the vocal cord problem. Clinic notes dated (b)(6) 2013, note that the ent confirmed that vns discharges appear to be affecting the left vocal cord function, which may be compromising respiration in the context of his right-sided cyst. It was reported that device diagnostics were within normal limits. The physician may try to adjust device settings and then send the patient back to ent for reevaluation. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3418880

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