Pages: [1] 2 3 ... 10
 1 
 on: Today at 08:59:16 AM 
Started by dennis100 - Last post by dennis100
Event Date 02/27/2013
Event Type  Injury   
Event Description
It was reported that the patient has a defibrillator implanted. It is unknown to date if the defibrillator is related to the vns or if it is a separate event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3026370

 2 
 on: Today at 08:57:54 AM 
Started by dennis100 - Last post by dennis100
Model Number 103
Event Date 06/01/2012
Event Type  Injury   
Event Description
The reporter indicated via clinic notes dated (b)(6) 2013 to the manufacturer that the vns patient had been experiencing different seizure types under normal stimulation. The patient experienced a total of three tonic-clonic seizures in (b)(6) 2012, for which there was no clear reason why they occurred. The patient experiences atonic seizures, starting in (b)(6) 2012, weekly. These are drop attacks and the patient falls down with loss of consciousness. The patient had generator replacement surgery performed on (b)(6) 2013 due to reported end of service. The explanted generator will not be returned from the hospital per the hospital's policy. All attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3121521

 3 
 on: Today at 08:54:43 AM 
Started by dennis100 - Last post by dennis100
Event Date 04/05/2012
Event Type  Injury   
Event Description
No further information is known about this patient's seizure history as this patient is a new patient to their current neurologist.

Event Description
Clinic notes were received in regards to a vns patient. It was reported that a vns patient has a history of having myoclonic seizures. Frequency: 25-30 per day on (b)(6) 2012. Since their last visit on (b)(6) 2012, her seizures almost completely resolved with the addition of onfi. Her teachers said that they did not note any seizures at all. However, in the past two weeks, the seizures have recurred and have started again at approx 10 per day. Vns settings (from (b)(6) 2012): 2. 00 ma / 20 hz / 250 pw / 7 seconds on time / 0. 2 minutes off time 2. 25 ma / 7 seconds ont time / 250 pw. It was reported at their (b)(6) 2012, visit that their seizures have worsened since the last visit. She was previously having about 10-15 seizures per day. She is currently having about 25-30 seizures per day, and mom thinks her balance is always off. Mom also thinks that the seizures are slightly stronger, as the jerk is stronger and she is more disoriented after the seizures. Seizures have always been persistent and daily, but significantly worsened recently. A medication was added onfi. The relationship of their seizures to their vns is unknown at this time. It is not known if they are above their prevns seizure rates or if a return to baseline. Unknown if a new seizure type, good faith attempts are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2945883

 4 
 on: Today at 08:52:53 AM 
Started by dennis100 - Last post by dennis100
Model Number 102
Event Date 01/01/2013
Event Type  Injury   
Event Description
On (b)(6) 2013 it was reported that the patient was referred for generator replacement due to "discomfort and movement". It was previously reported that the patient's vns was at end of service; but diagnostics later confirmed that the device was not at end of service. It was later clarified that the "movement" was migration of the vns generator. Clinic notes were received dated (b)(6) 2013 that state the patient is awaiting prophylactic surgery for her generator to be replaced due to discomfort and movement. The patient has a medical history of copd and went to the e. R. With difficulty breathing during a seizure on (b)(6) 2012 and to the e. R. On (b)(6) 2013. The clinic notes dated (b)(6) 2013 indicate that the patient states her magnet mode stays on after a magnet swipe and she has to hold the magnet over the generator for a few minutes so that it will go back. It was later reported that the patient first noticed the device started moving around a couple of months ago after being admitted to the hospital for west nile virus. A cat scan had been performed at that time. The patient also started experiencing a burning pain at the generator which goes up to the neck that occurred with stimulation. The patient also mentioned that the magnet stimulation is particularly painful, and mentioned that when the device is swiped, it will stay on at the magnet settings until she holds the magnet over it to disable the stimulation. The patient said, after doing so and removing the magnet, it will go back to the normal generator settings. The patient says they have tried to make changes to the parameter settings to lessen the painful stimulation but there has been no improvement. The patient said she discussed this with the implanting physician who told her the device "is probably messed up". The manufacturing records for the generator were reviewed and the device met all specifications prior to distribution. Good faith attempts for further information from the physician have been unsuccessful to date. Although surgery is likely, it has not yet occurred.

Event Description
The surgeon's office reported that it was unknown if a non-absorbable suture was used to secure the generator to the fascia during implant surgery as it was not in records.

Manufacturer Narrative

Manufacturer Narrative
Age at time of event, corrected data: the initial report reported the age incorrectly.

Event Description
On (b)(6) 2013 it was reported that the patient saw another neurologist and it was determined that she does not have epilepsy so she wants the vns removed.

Event Description
It was reported that the patient's vns device was removed on (b)(6) 2013. Attempts were made for additional information and product return; however, they were unsuccessful.

Event Description
It was reported that the explanted generator was discarded by the hospital. Therefore, analysis cannot be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3025829

 5 
 on: Today at 08:51:08 AM 
Started by dennis100 - Last post by dennis100
Model Number 302-20
Event Date 02/01/2013
Event Type  Malfunction   
Event Description
The patient had generator and lead replacement surgery on (b)(6) 2013 due to painful stimulation and the patient felt as if the device was flipping. The explanted products were received by the manufacturer on (b)(4) 2013. However, product analysis has not been completed to date.

Event Description
An analysis was performed on the returned lead portions which identified observed abraded openings on the outer and inner tubing sections have the potential for contributing to the painful stimulation allegation. The abraded opening found on the outer and one inner silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and one of the inner silicone tubes. For the observed inner tubing fluid remnants found inside the second inner silicone tubing, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. Other than the abraded openings of the outer and inner tubing, no additional obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. One set of setscrew marks was found near the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time. However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is evidence of an abraded opening in the inner tubing, which may have contributed to the stated painful stimulation complaints. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator.

Manufacturer Narrative
Suspect medical device, corrected data: with the product analysis results, the initial report inadvertently reported the suspect device incorrectly. Device manufacture date, corrected data: with the product analysis results, the initial report inadvertently reported the suspect device incorrectly. Device failure occurred, and may have contributed to the patient's pain. Review of lead manufacturing records confirmed that all quality tests were passed prior to distribution.

Manufacturer Narrative

Event Description
It was initially reported that the patient was referred for surgery due to the device slipping. Diagnostics are fine but the patient feels pain. Clinic notes dated (b)(6) 2013 were received due to the patient being referred for surgery. The generator was disabled due to currently experiencing "pain in her neck over the scm muscle as it did once prior in 2006 when revision was needed, because the device had slipped out of place". The events in 2006 were previously reported in mfg report number: 1644487-2013-00840. It was noted by the surgeon that the lowest lead connection was off of the nerve, which was putting traction on the nerve. Releasing the tension moved the nerve back to a more normal position. The surgeon described the patient's tissue as "weakened", and that the tissues might be consistent with an underlying collagen vascular disorder. The patient's "tissue", specifically the fascia and collagenous tissues were described as weakened and lacking the usual texture that these tissues should demonstrate and it is suspected the patient has an underlying collagen vascular disorder. It is unclear if the possible collagen disorder caused the lead to migrate. No trauma occurred. It was further indicated in the notes that the patient had noted pain with vns stimulation on times for the past month described as focal pain at the electrode site. The patient's seizures are under good control, but the vns device was turned off due to "lead impedance problems and elevated dc code and pain". However, diagnostics were within normal limits. System diagnostics showed dcdc=2, and normal mode diagnostics showed dcdc=3. Additionally, the lead impedance was indicated as "ok". The physician also stated the generator is not at eos, "but we believe it is disconnected. " x-rays were ordered, and the patient was referred for vns replacement surgery due to painful stimulation which the physician indicated the pain could preclude injury. Upon follow-up with the treating physician, it was reported that they are unable to establish communication with the device currently but then it was later indicated that the device could be interrogated to show the impedance. Current x-rays do not show any obvious discontinuities, but they have not been provided to the manufacturer for review to date. The x-ray report indicates the x-rays were compared to those dated (b)(6) 2006 and there were no evidence of lead disruption or significant displacement identified. Additionally, there was no gross discontinuity involving the stimulator although evaluation was reported to be quite limited. No patient or manipulation is believed to have contributed to the events. The physician does not believe the leads are disconnected and does not believe that there is lead migration at this time. There were no causal or contributory programming or medication changes that preceded the onset of the events. After the device was turned off due to pain in the generator and lead area, the pain stopped. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3027440

 6 
 on: Today at 08:49:42 AM 
Started by dennis100 - Last post by dennis100
Model Number 300-20
Event Date 01/15/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013, it was reported that this vns patient was feeling painful stimulation for an unknown reason and was referred for surgery. Follow-up with the physician indicated that the patient began on (b)(6) 2103. The patient's last programming change had been on 11/26/2102. No recent patient manipulation or trauma occurred that is believed to have caused/contributed to the event. The patient's device was disabled. The patient was at the electrode site. The patient was having her vns replaced to have the discomfort reduced. X-rays were taken but have not been provided to review. The patient underwent full revision on (b)(6) 2013. An implant card received on (b)(4) 2013 reported that this was due to a lead fracture. Follow-up with the surgeon showed that x-rays were taken prior to surgery, and a lead fracture was identified. No other additional information was available. The explanted devices were discarded.

Manufacturer Narrative
Device failure is suspected but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3018974

 7 
 on: Today at 08:48:53 AM 
Started by dennis100 - Last post by dennis100
Model Number 102
Event Date 01/27/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
Reporter indicated the patient had vns generator replacement surgery on (b)(6) 2013. The explanted vns generator will not be returned from the hospital as the hospital discards explanted devices.

Event Description
All attempts to the reporter have been unsuccessful to date. Vns replacement surgery is still currently planned, but has not occurred to date.

Event Description
Reporter indicated a vns patient was experiencing painful stimulation in the neck for the previous month. Vns device diagnostics indicated normal device function, and the vns is not at end of service. However, the patient has been referred for vns generator and possible lead replacement surgery due to the painful stimulation. Review of available vns programming history for the patient noted the patient has been on very low duty cycle settings, with 7 seconds on and 5 minutes off. The off time was also set to 10, 15, 20, 30, and 50 minutes off previously. Attempts for additional information are underway. Surgery has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3023377

 8 
 on: Today at 08:47:13 AM 
Started by dennis100 - Last post by dennis100
Model Number 103
Event Date 10/03/2008
Event Type  Injury   
Event Description
Reporter indicated via the operative note received to the manufacturer that the vns lead was not replaced during the (b)(6) 2013 surgery as was originally reported; only the generator was replaced. The lead was not replaced as vns systems diagnostics performed during the surgery were ok with 5 tests with the new vns generator and resident lead. There was felt to be a "possible abnormality" of the lead prior to the surgery per the note.

Manufacturer Narrative

Event Description
Reporter indicated a patient's vns generator and lead were to be replaced as he felt there may be a malfunction occurring with the generator, as the patient had not been able to achieve the same level of efficacy as the previous vns generator and was having increased seizures. The patient was also experiencing pain in his neck. Follow up with the reporter revealed vns diagnostics were within normal limits, indicating proper function. The reporter felt a lead issue may be occurring that was causing the increase in seizures and neck pain. The cause of the neck pain is unclear, as the patient was grabbing at his neck causing self-trauma and this may be what the pain was due to, or it may be the vns stimulation. It is unknown as the patient is nonverbal. It was felt the increased seizures may be caused by a device malfunction or the patient's other comorbidities. It is not known if more than one seizure type was increased, or the level of the increase, other than they were increased. There were no precipitating events. The patient had vns lead and generator replacement surgery performed on (b)(6) 2012. The explanted devices will not be returned per hospital policy.

Event Description
Reporter indicated the patient's seizures and neck pain have improved since the vns lead and generator were replaced.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2944969

 9 
 on: Today at 08:46:04 AM 
Started by dennis100 - Last post by dennis100
Model Number 302-20
Event Date 08/25/2006
Event Type  Injury   
Event Description
Reporter indicated that during a patient's vns generator replacement surgery due to end of service on (b)(6) 2006, it was noted by the surgeon that the lowest lead connection was off of the nerve, which was putting traction on the nerve. Releasing the tension moved the nerve back to a more normal position. The surgeon described the patient's tissue as "weakened", and that the tissues might be consistent with an underlying collagen vascular disorder. The patient's "tissue", specifically the fascia and collagenous tissues were described as weakened and lacking the usual texture that these tissues should demonstrate and it is suspected the patient has an underlying collagen vascular disorder. It is unclear if the possible collagen disorder caused the lead to migrate. No trauma occurred. The patient was also reported as experiencing neck pain at the time along with the lead migration.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3023975

 10 
 on: Today at 08:45:15 AM 
Started by dennis100 - Last post by dennis100
Model Number 302-20
Event Date 02/21/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected but did not cause or contribute to a death or serious injury.

Event Description
On (b)(6) 2013, it was reported that eri=yes was seen, and system and normal mode diagnostics indicated high impedance (dcdc=7, output status: limit, impedance: high). The patient complained about pain in the neck in specific positions. The patient suffered from a drop attack in october last year. Shortly after that the both tests were normal. The generator was disabled. Attempts for additional information have been unsuccessful. An implant card indicated that the patient underwent full revision (b)(6) 2103. The explanted devices have not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3018362

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