Pages: 1 ... 16 17 [18]   Go Down
Print
Author Topic: Misc. Pain  (Read 21218 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61035


« Reply #510 on: April 08, 2019, 02:58:53 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/01/2006
Event Type  Injury   
Event Description
A voluntary mdr report that was submitted 01/16/2019 was received to the manufacturer's. It was reported that in 2006 when the device was implanted, the patient began to have pain and 6 days later, the incision site opened, leaking blood and pus, with extrusion of the lead wire. The patient had the lead removed and 22 days later the device was reportedly "hanging outside the body" and the patient was readmitted to the hospital for surgery to remove the device. Then 3 months after, the patient noticed a 4-5' tube sticking out of the incision site that was draining large amounts of pus. The patient stated that she suffers from post-traumatic stress related to this case. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8389686
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61035


« Reply #511 on: April 08, 2019, 02:59:42 AM »

Model Number 302-20
Device Problem Fracture
Event Date 02/07/2019
Event Type  Malfunction   
Event Description
It was reported that a patient's device was showing high impedance. This was confirmed with a second programming system. The patient also verbalized pain around the neck site and an increase in seizures. The physician ordered a chest x-ray. It was unknown if the patient's pain was occurring with stimulation or not as no further information could be obtained through the facility. The x-rays were inconclusive and the patient was referred for full revision. It was noted that the patient had recently sustained a signification fall. The device is turned off at this time. No known surgery has occurred to date. It was noted that the explanted devices would be expected for return. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8386306
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61035


« Reply #512 on: April 08, 2019, 03:00:21 AM »

Model Number 302-20
Device Problems Mechanical Problem; Device Contamination with Body Fluid
Event Type  Malfunction   
Event Description
A patient's generator and lead were removed at the patient's request. This explant surgery and related reports of pain were captured in mfg report #1644487-2018-02291. Product analysis was completed on the returned lead product. The lead assembly was returned in one portion with one loose tie down; the electrodes were not returned. Setscrew marks were observed on the connector pin, providing evidence of proper mechanical and electrical contact between the generator and connector pin at one point in time. Abraded openings of both the outer and inner tubing were identified in the returned lead portion. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. With the exception of the abraded openings, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8389896
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61035


« Reply #513 on: April 08, 2019, 03:00:55 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/05/2007
Event Type  Injury   
Event Description
It was reported that a patient's device was turned off "10 years ago" as it did not help her, but actually increased her seizures. The patient also reported feeling discomfort from the device. Review of the manufacturer's programming history found no device diagnostics and noted that the device was turned off in 2007 after being titrated up to output current of 1. 25ma normal mode stimulation. No anomalies were noted. No further relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8394341
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61035


« Reply #514 on: April 08, 2019, 03:01:36 AM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/07/2004
Event Type  Injury   
Event Description
It was reported that the patient's vns generator was turned off due to the patient experiencing discomfort. The patient was referred for generator replacement. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8394213
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61035


« Reply #515 on: April 08, 2019, 03:02:35 AM »

Model Number 304-20
Device Problem Fracture
Event Date 02/01/2019
Event Type  Malfunction   
Event Description
It was reported that a patient was reporting ear pain and used his magnet to stop stimulation. According to the patient, this stopped the ear pain. When the patient returned to the office, the doctor decided to turn off and restart the titration from 0. 25 ma. When the adjustments were made, a high impedance message was noted. The physician asked for the patient to get "image tests" (likely x-rays). The patient's wife reported that a couple of weeks ago he had a severe seizure and fell flat on the floor. It's unclear if this may have caused the high impedance or if the seizure was a result of the high impedance. No additional information has been received to date and no known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8420858
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61035


« Reply #516 on: April 09, 2019, 12:52:40 AM »

Model Number 300-20
Event Date 12/01/2012
Event Type  Malfunction   
Event Description
It was reported that the patient's vns lead had experienced a fracture. It was not made apparent how the initial reporter determined there was a fracture problem. The device was reportedly disabled in (b)(6) 2012 in relation to this issue. Surgical intervention has not occurred to date. Attempts for additional pertinent information have been unsuccessful to date.
 
Event Description
It was reported that the patient's explanted generator was discarded following surgery. No additional pertinent information has been received to date.
 
Event Description
Follow up attempts with the treating physician showed that although a lead break was suspected, it was never confirmed. X-ray images according to the treating physician showed no visible fracture. The vns was reported to have been "interrogated" few times with no abnormal results. The patient complained of pain at the time of the device disablement. The pain was occurring in the area of the left axilla and radiated into the upper left chest and neck, and did not coincide with stimulation. The patient's generator was explanted on (b)(6) 2016. The device has not been returned to the manufacturer to date. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5697512
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61035


« Reply #517 on: April 09, 2019, 12:53:41 AM »

Model Number 302-20
Event Date 01/01/2010
Event Type  Injury   
Event Description
The patient reported on (b)(6) 2016 that her lead is protruding and is painful because she has lost a lot of weight. She stated she lost weight and device migrated and she has a knot where she thinks the wire connected to the generator. The patient needs a mri for her left breast but the generator is right above. Follow-up with the physician showed that she needs an explant asap and it's not clear if she needs it only for the mri or for the pain, protrusion and migration too. The physician states that the pain, protrusion and migration were present before her weight loss but now the device is more prominent in her neck since her 100 lb weight loss. The mass at her connector site of the lead and generator is believed to possibly be from the lead coming loss (probably from migration of the system). From the report it seems as though the lead is protruding, painful in the neck and possibly migrating causing a mass near the generator connection. Surgery has not occurred to date.
 
Event Description
Information was received from the physician on (b)(6) 2016. It was stated that the reason for the explant was due to the need for mri for breast lump, patient was a non-responder to vns therapy anyway, and patient was experiencing pain, protrusion and migration. It was stated that the patient experienced more pain after the weight loss. The issues began 6 to 7 years ago. No surgical intervention has not occurred to date.
 
Event Description
It was reported on (b)(6) 2016 that the patient had her device explanted that day. The explanted devices were disposed of.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5834683
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61035


« Reply #518 on: April 10, 2019, 01:39:37 AM »

Event Date 07/21/2016
Event Type  Injury   
Event Description
A cyberonics vns implant for epilepsy malfunctioned and the device could not be shut off by the patient's magnet. This caused much pain, fear, and the patient to incur bruising. The patient, after trying to turn it off and it getting worse, had his pregnant wife drive him to the emergency room of the hospital where the device was implanted and where the neurologist he was seeing was practicing, which was over an hour away. Emergency room personnel could not shut off the device, but taped a pace maker magnet on his chest and told him he could go home. He insisted on being admitted because he lives over an hour away, the device had not yet been shut off. He told them he'd sleep in his car if he had to. They could not contact his old neurologist (she recently left that hospital, but there was no forwarding information) and he had not yet seen his new neurologist. They finally admitted him for 'observation. ' the neurologist they finally had come look at him knew nothing about the device and it took considerable pleading from the patient for them to find someone who could shut it off. Further, the staff treated the patient as if he was crazy or at least not in full control of his faculties, yet they never contacted a psychiatrist. The patient was in full control of his faculties and was the one explaining the device to health care providers. It turned out that the device was not only erratic and shocking him continuously for long periods of time, it was also set too high. If they had not found a representative that sold the devices to come and shut it off, it could have been life threatening. That kind of stress and not being able to get enough sleep are triggers for the epilepsy. He can't breathe sometimes when that device goes off normally, much less in that mode, and it had to have been hard on his heart, not to mention the bruising and pain he was in. He was also scared and many of the people treating him were condescending, rude, and when the patient asked them about (b)(6) (where he doctored for years), the neurologist said she'd never heard of it and brushed it off. Have they not heard of (b)(6)? the rep for the device claimed they'd never had anything like that happen and certainly not any that caused injury or death, which i found out was not true when i checked the fda website. I don't know that the medical personnel or the manufacturer will report this, and it needs reporting. It's currently turned off and he was able to come home, but he wants it removed and they keep advising him not to remove it. If it has malfunctioned, why would you not want to at least remove it or the battery?.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5836193
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61035


« Reply #519 on: April 10, 2019, 01:40:20 AM »

Model Number 102
Event Date 05/01/2016
Event Type  Malfunction   
Event Description
It was reported that the patient started experiencing pain at the generator site recently. The pain was not reported to be associated with stimulation. The pain is however causing the patient to have panic attacks which lead to increased seizures. Patient was provided a neurologist contact information and asked to follow up with the physician regarding the concerns. However, no additional relevant information was received.
 
Event Description
Additional information was received that the patient is still having pain in his arms/legs and generator site, but this pain is present even when the device is "off. " patient has held the magnet up to his generator for 5 minutes at a time t temporarily disable stimulation, and experiences worse pain during the disablement. The pain often wakes him from sleep and he wakes up in a sweat. Patient said that a doctor has mentioned that this could be related to anxiety, but it has not been confirmed. Additional information was received that the patient's vns settings were programmed at unusual setting of 30 seconds on time and 150 minute off time. The reason patient was feeling pain during the stimulation was because the settings were too high and there was a long break in between. The physician adjusted the patient's settings to a normal duty cycle and reduced the output current but the settings and diagnostics were not provided. Seizure patterns will be evaluated on an ongoing basis now that the vns has been programmed appropriately.
 
Event Description
Patient underwent explant surgery due to shoulder and neck pain. The physician stated that the patient demanded it be removed due to shoulder and neck pain. A portion of the lead was cut but the electrodes remain implanted. No other relevant information was received.
 
Event Description
Follow-up was later received that the patient will have the remaining portion of the lead removed. The additional surgery is not known to have occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5704559
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61035


« Reply #520 on: April 11, 2019, 10:15:22 AM »

Model Number 304-20
Device Problem High impedance
Event Date 07/23/2014
Event Type  Malfunction   
Event Description
It was reported that the patient was seen in the physician¿s office due to the previous night¿s experience of a choking that woke her up. This reportedly started occurring on (b)(6) 2016. The patient taped the magnet over the device which reportedly helped the issue. When the magnet was removed, the patient began having problems again. However, the experiences of breathing difficulties, choking sensations, and pain were not consistent and occurred erratically. The physician¿s office decided to disable the device. Device diagnostics were reported to be within normal limits at that time. There was no recollection of contributing trauma. A review of the available programming history showed that the device diagnostics that occurred in office were all within normal limits. The current outputs of all the device diagnostics matched the programmed levels. The downloaded internal device data was reviewed. The last >25% change in impedance was estimated to occur on (b)(6) 2015. The pre-change value was 4925 ohms and the post-change was 2820 ohms, representing change within normal limits. The historic >25% changes history showed evidence of intermittent high impedance as far back as (b)(6) 2016, where 14188 ohms was registered in that day's automatic 24-hour check. The generator and lead dhrs were reviewed and found that all specifications were met prior to distribution. Surgical intervention has not occurred to date. No additional pertinent information has been received to date.
 
Manufacturer Narrative
Initial reporter also sent report to fda, corrected data: initial report incorrectly stated it was unknown if the initial reporter submitted a report to the fda.
 
Event Description
X-ray images of the patient's vns were reviewed by the treating physician. The assessment noted that no gross discontinuities could be observed in the device lead. X-ray images of the patient's vns were received by the manufacturer for review. The generator was placed normally per labeling. The connector pin of the lead could not be visualized past the connector block. The feed thru wires appeared to be intact. The lead electrodes appeared to be appropriately placed per labeling. There were no apparent sharp angles or gross fractures of the lead that could be seen in the images given. A small segment of the lead was obscured by the generator and could not be fully assessed. Based on the x-rays received, the cause for the previously encountered high impedance could not be determined with certainty. No additional pertinent information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The patient¿s generator replacement surgery was completed. Lead impedance was within normal limits within the replacement surgery. The suspect lead was not replaced at that time. The explanted generator is expected to return to the manufacturer for analysis, but has not been received to date.
 
Event Description
The explanted generator was received by the manufacturer. Product analysis is underway, but has not been completed to date.
 
Event Description
Product analysis was completed on the returned generator. Visual examination showed observations consistent with an explant procedure. No surface abnormalities were noted on this device. Additionally, the septum was not cored, eliminating the possibility of a potential unintended electrical current path. The device output signal was monitored for more than 24-hrs in a simulated body temperature environment. Results showed no signs of variation in the output signal, and the device provided the expected level of output current. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. Magnet activations performed during output monitoring demonstrate the appropriate magnet output for the programmed settings. The pulse generator accounted for the correct number of magnet activations that were performed. A comprehensive electrical evaluation showed that the pulse generator performed according to functional specifications. The battery showed an ifi=no battery status and measured at 3. 062 volts. The internal device data showed that 29. 500% of the battery had been consumed. Review of the internal device data showed historic instances of increased impedance as previously reported. There were no performance or any other type of adverse condition found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5796039
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61035


« Reply #521 on: April 11, 2019, 10:16:07 AM »

Model Number 304-20
Event Date 04/01/2016
Event Type  Injury   
Event Description
It was reported that the patient had a lump under her jaw. She was experiencing pain and flushing with and without device stimulation. The physician evaluated the lump and assessed that it was related to the vns lead but was unsure how. The patient was referred to a surgeon for evaluation and after the evaluation she was referred for lead revision surgery. No surgical interventions are known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient underwent exploratory surgery on her neck at the vns electrode site. During the surgery the surgeon removed an existing tie down because he believed it was too superficial and along with scar tissue it was causing the mass and pain in the patient's neck. The surgeon left a second tie in place since it was deeper and he did not believe it was contributing to the mass or pain. The vns lead and generator were left implanted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5780196
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61035


« Reply #522 on: April 12, 2019, 01:28:07 AM »

Model Number 300-20
Event Date 01/01/2016
Event Type  Malfunction   
Event Description
Patient underwent explant due to pain as reported in mfr. Report # 1644487-2016-01153. An analysis was performed on the returned lead portions. The electrodes portion of the leads was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. Abraded openings were found on the outer and inner silicone tubing. These abraded openings and the cut ends that were made during the explanted process most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the marked connector boot and identified the deposit as containing silicon, phosphorus, sodium, magnesium, sulphur and calcium. Refer to attached eds sheet for additional information. With the exception of the inner tubing abraded opening, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings, there is evidence of an inner tubing abraded opening.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5778892
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61035


« Reply #523 on: April 13, 2019, 04:53:59 AM »

Model Number 105
Event Date 06/04/2016
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that patient has delayed post op infection, not oozing any further; patient was given antibiotics. It was reported that vns was turned on 0. 25ma, patient did tolerate the therapy. Additional information was received that patient was implanted on (b)(6) 2016. Initially both electrode and generator sites were sore and after around two weeks on implant, the wound on generator site was oozing. Additional information was received that the wound has healed now.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Further information was received on (b)(6) 2016 that the neurologist is referring the patient back to the surgeon for further assessment of the wounds, they remain very sore/painful, and do look quite raised. Review of manufacturing records confirmed sterilization with hp for the lead and the generator prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5905945
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61035


« Reply #524 on: April 13, 2019, 04:55:28 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was experiencing pain, device protrusion and generator migration following a mammogram procedure. The pain and protrusion were stated to be at both the lead and generator sites. The patient stated that she was thin and that her lead was always visible, but since the mammogram it protruded more than it had previously. A revision surgery was reported to have been scheduled at the time of the report, but has not been known to occur to date. No additional pertinent information has been received to date.
 
Event Description
It was reported that the patient had a revision surgery on (b)(6) 2016. The generator found to be "completely floating around" in the generator pocket and was "upside down". It was reportedly loose enough that the surgeon could spin it in a circle. During the surgery, the surgeon observed that a tie-down was not attached and was re-attached. The generator was also re-secured, and more slack was given in the neck for the lead. In the previous generator implant, the surgeon reportedly did not place a suture to secure the generator. The patient did not have an issue with vns placement until the mammogram. No additional pertinent information has been received to date.
 
Event Description
The patient reported that the stabbing pain she previously reported was still present. Her vns was subsequently turned off. The pain in the neck was reported to have resolved with the generator disabled. The patient reportedly still experienced occasional sharp pain at the generator site not coinciding with stimulation. This pain cannot be predicted and does not appear to happen with any specific movement or body position. The patient expressed that she wanted the generator explanted. She feels the m106 generator is too large for her thin body. No known additional surgical intervention has occurred to date. No additional relevant information has been received to date. ¿.
 
Event Description
Follow up with the office of the surgeon who performed the revision surgery showed that he likely used a suture to secure the generator in the previous generator replacement surgery. Attempts for additional pertinent information regarding the revision surgery have been unsuccessful to date. Further information showed that the patient was still experiencing pain and ¿shocking¿ sensations. The device was reported to be off at the time of this report. No additional pertinent information has been received to date.
 
Event Description
The patient was reportedly still experiencing pain. The device was reported to still be set to not deliver current at the time the patient experienced the pain. No additional pertinent information has been received to date.
 
Event Description
It was reported that the patient had her vns generator and lead explanted due to discomfort and painful stimulation. The explanted devices have not been returned to the manufacturer to date. No additional pertinent information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Communication from the treating physician showed that the patient¿s pain had continued following cessation of stimulation. Settings and device diagnostic results were provided from the appointment where the device was disabled. The physician reportedly endorsed that the pain began following a mammogram procedure which pulled the vns lead. The explanted lead and generator were received by the manufacturer for product analysis. Product analysis was completed on the returned lead portion. The returned portion measured 336 mm. The continuity measurements taken during decontamination verified an electrical and mechanical contact between the generator and the connector block to the end of lead. Visual analysis showed that the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. The set screw marks found on the lead connector pin provide evidence that a good mechanical and electrical connection was present at least at one time. Continuity checks of the returned lead portion were performed and no discontinuities were identified. There is no evidence to suggest an anomaly with the returned portion of the device. Note that a portion of the lead assembly including the electrodes was not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. Product analysis was completed on the returned generator. Visual examination showed only observations consistent with the explant process; no surface abnormalities were noted on this device. The device output signal was monitored for more than 24-hrs in a simulated body temperature environment. The pulse generator showed expected level of output currents and no signs of variation. Both interrogation and system diagnostic tests were performed. Various electrical loads were attached to the pulse generator, and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured 3. 051 volts during functional testing and showed an ifi=no condition. The internal device data showed that 12. 492% of the battery had been consumed. Review of the remainder of the internal device data showed no anomalies. There were no performance or any other type of adverse conditions found with the pulse generator. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5909344
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61035


« Reply #525 on: April 14, 2019, 01:45:26 AM »

Model Number 105
Event Date 11/15/2016
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported by the patient that she had a generator pocket revision on (b)(6) 2014 for the sake of comfort. It was later explained by the physician's office that the patient initially thought she had an infection as she had a fever and the generator site was red; however, the physician ruled out infection. The patient noted she had a stinging pain which was worse with movement. It was confirmed the surgery was performed due to pain, and not to preclude a serious injury.
 
Manufacturer Narrative
This information was inadvertently incorrectly reported on the initial mfr. Report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5876872
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61035


« Reply #526 on: April 15, 2019, 01:37:27 AM »

Model Number 103
Event Date 08/29/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
Clinic notes were received for a patient providing that she was experiencing sudden pain with swallowing and with turning of the head. Reducing the output and also lowering the pulse width did not improve the pain. Diagnostics were within normal limits. The patient is in referral for surgery, however no known surgery has occurred to-date. Additional relevant information has not been received to-date.
 
Event Description
Follow-up to the treating physician provided the pain was located in the patient's neck area around the lead. Diagnostics were reported to be within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5978720
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61035


« Reply #527 on: April 16, 2019, 01:27:01 AM »

Model Number 302-20
Event Date 08/14/2014
Event Type  Malfunction   
Event Description
During review of the in-house programming/diagnostic history database, it was observed that high impedance was observed at office visit on (b)(6) 2014. It is unknown if any patient manipulation or trauma occurred that could have caused or contributed to the high impedance reading. It is unknown if surgery has been performed. The device was programmed off on (b)(6) 2014. The physician's office was notified of the high impedance event and the manufacturer's recommendations when high impedance is observed. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient was experiencing pain in his left jaw, neck and shoulder during the visit when the high impedance was observed. The physician then disabled the device in response to the pain. Due to the diagnostic results observed during the visit, it appears that the pain was related to the lead fracture. No additional relevant information has been received to date.
 
Manufacturer Narrative
Corrected data: outcomes attributed to adverse event; this information was inadvertently left off on mfg. Report #1.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5970450
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61035


« Reply #528 on: April 16, 2019, 01:27:42 AM »

Model Number 302-20
Event Date 09/01/2015
Event Type  Injury   
Event Description
It was reported that a patient had full revision surgery due to an unknown reason. Further information was received indicating that the full revision was done because the patient experienced pain in the left upper extremity, which, according to the surgeon, was due to the placement of the original lead. The cause of the pain was due to lead migration. However, the cause of the migration was unknown. The physician reported that the surgery was done for patient comfort and to preclude a serious injury. The explanted generator and lead were received on 08/10/2016. Analysis of the lead identified no anomalies. Analysis of the generator also identified no anomalies. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5962153
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61035


« Reply #529 on: April 17, 2019, 07:14:44 AM »

Model Number 302-30
Event Date 07/26/2016
Event Type  Malfunction   
Event Description
It was reported that high impedance was found for a patient's device on (b)(6) 2016. The patient was reported to have had a fall recently, which may have caused a fracture and the high impedance. No known surgical interventions have occurred to date.
 
Event Description
Clinic notes were received for patient's referral for vns replacement. Notes indicate that the patient had two falls and reported pain in the left neck and tingling sensation. The doctor noted that the patient has a inactive vns. Previously the psychiatrist intended to replace the vns battery only when it reach eos. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5947860
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61035


« Reply #530 on: April 19, 2019, 01:34:58 AM »

Model Number 102
Event Date 07/01/2016
Event Type  Injury   
Event Description
It was initially reported the patient was referred to have his device removed; however, the reason was unknown. During investigation it was noted the patient's device had been programmed off for over 5 years and the vns was now " bothering him", which is why he was having the device explanted. The programming history database was reviewed, which provided information from (b)(6) 2008. No anomalies were noted within the data available and the device was working as expected. A battery life calculation was performed which showed the battery would have been depleted approximately 5 years ago. Further investigation showed that " bothering him" meant that when he turned his neck there is discomfort and when he lies on his side, it feel like the generator is shifting. Attempts for additional informational relevant information have been unsuccessful to date.
 
Event Description
It was clarified that the patient's discomfort occurs when he turns his neck and also when he lays on his side, it feels like the generator is shifting. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5924125
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61035


« Reply #531 on: April 21, 2019, 03:48:22 AM »

Model Number 103
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by the patient that she was having pain in her neck area. The pain was later described as a sharp-jabbing pain in her neck and feels as if the "lead is broken in half and the wires are poking" into her neck. It was noted by the physician that the patient does have a history of hypersensitivity. The programming history database was reviewed and it showed that the patient's generator was functioning as intended on (b)(6) 2016 and the impedance values was within normal limits. The patient was seen by the physician on (b)(6) 2016 and it was noted the impedance was still within normal limits and working correctly. X-ray images were reviewed by the manufacturer and it was found that the vns tie-downs, which hold the lead in place, appeared superficial in the neck. No cause for the patient's pain could conclusively be determined by the company representative that reviewed the x-rays; however, the patient's surgeon was interested in reviewing the images. The patient had been referred to a surgeon for possible replacement due to the reported pain. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was later reported the patient had been seen by the neurosurgeon for an assessment as he was trying to determine the best step to take for the patient. It was noted the diagnostics continued to come back as normal and the patient feels like she needs to be turned back on as she was getting seizure control when the device was programmed on. However, it was noted when the device was turned on, the patient was having voice discomfort, but she also had a hoarse voice when the device was programmed off. Additional information was received stating the patient is returning to rhode island and her previous surgeon will be explanting the device as she does not want it anymore. It is unknown if the device is being explanted due to the reported poking feeling, due to the reported voice issues, or both. The reports of vocal cord paralysis and associated symptoms have been captured in mfr. Report 1644487-2016-02397. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was later reported by the surgeon that he had explanted the patient's vns generator and lead due to a presumed malfunction. The exact date of the explant was not provided. Attempts for additional relevant information from the surgeon have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6096833
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61035


« Reply #532 on: April 21, 2019, 11:43:29 PM »

Model Number 103
Event Date 08/01/2016
Event Type  Injury   
Event Description
It was reported that the patient planned to have her vns explanted. The patient was involved in an atv accident which reportedly caused the generator to migrate and caused associated pain. The patient elected to have the device explanted in relation to satisfactory control without vns therapy. Further information received showed the patient was also to have an mri performed in relation to the atv accident and pain, which contributed to the decision to have the device removed. Device explant has not been reported to have occurred to date. Attempts for additional pertinent information have been unsuccessful to date.
 
Event Description
Follow up communications were completed with the respective offices of the treating neurologist and surgeon. The patient had her vns system fully explanted on (b)(6) 2016. The surgeon reported that the explant was exclusively for the desire for an mri. However, the treating neurologist noted the occurrences of the previously reported migration and pain that contributed to the decision to perform surgery. The patient had a recent atv accident that caused pain, swelling, and occasional burning sensations at the generator site. The generator was previously able to be repositioned at will by the patient, but was fixed in place after the accident. The device migrated from its implant location and caused discomfort related to its position. The treating neurologist assessed that the vns was causing discomfort after the atv accident. The surgery was not to preclude a serious injury per the treating physician. Following explant surgery, the patient was reportedly feeling better regarding the reported pain. The device was reported to previously have impedance within normal limits and a full battery. No additional pertinent information has been received to date.
 
Event Description
The explanted lead and generator were reportedly discarded by the explanting hospital. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6084255
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61035


« Reply #533 on: April 21, 2019, 11:44:25 PM »

Model Number 302-20
Event Date 10/01/2016
Event Type  Injury   
Event Description
Information was received which indicates that the patient was having severe pain in their neck. The surgeon elected to perform exploratory surgery on (b)(6) 2016 to identify if any anomalies were present causing the patient's pain. The physician did not find the patient's source of pain and made no corrections to the vns system. No other relevant information has been obtained to date.
 
Event Description
Information was received which indicates that the patient was having discomfort in their neck. The surgeon elected to perform exploratory surgery on (b)(6) 2016 to identify if any anomalies were present causing the patient's pain. The result of this surgery is unknown. No other relevant information has been received to date.
 
Event Description
Information was received which indicates that the patient had severe pain around the vns after they replaced the battery which required another surgery to rearrange the device and the wires. The surgeon opened the patient's chest incision and turned the patient's head to ensure there was enough slack in the lead. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6102862
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61035


« Reply #534 on: April 22, 2019, 03:25:31 AM »

Model Number 103
Event Date 10/19/2016
Event Type  Injury   
Event Description
A call was received from a physician stating that a patient was reporting that their lead neck site was "heating up" and the vns was causing pain at the chest wall. The patient was also experiencing jaw pain which stimulation, and her heart slowed down when the vns was stimulating. The patient stated that she was supposed to receive stimulation every 5 minutes but she was feeling the device go off every 30 seconds. A review of the available programming history showed that the patient's settings from (b)(6) 2012 had a 5 minute off time. The physician was told to use a magnet to inhibit stimulation for the patient. No further relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
A patient alleged that vns almost killed her, stating that it electrocuted her vagus nerve and the connected organs. The patient believed that her vns malfunctioned and contributed to years of pain and damage, leading her to have the device explanted 1 month prior to her report; however, no device malfunction has been identified to date. A review of programming history for the patient's device available from the date of implant through the next 2. 5 years indicated that the device functioned properly throughout the available history. The programming history indicated that the device was programmed off in march 2015. A physician who followed the patient in 2016 indicated that the device was programmed on in february, and programmed off again in october. The physician could not assess the cause of the patient's reported adverse events since the physician had only seen her twice in his clinic. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6096084
Logged
Pages: 1 ... 16 17 [18]   Go Up
Print
Jump to: