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dennis100
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« on: April 12, 2011, 04:36:47 AM »

Model Number 102
Event Date 07/24/2007
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Device mfg records were reviewed. Review of mfg records confirmed sterilization for both the generator and lead prior to distribution. Vns therapy labeling lists infection as a potential adverse event, related to surgery.

Event Description
Reporter indicated the patient was explanted because of an infection at the surgery site. The physician did not know what caused the infection. The explanted vns therapy system was discarded by the hospital after surgery; therefore, a product analysis will not be performed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=937401
« Last Edit: May 01, 2017, 12:37:15 AM by dennis100 » Logged
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« Reply #1 on: April 12, 2011, 04:37:24 AM »

Model Number 102
Event Date 10/25/2007
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated a vns pt's generator was explanted for infection. The pt was later reimplanted with a new generator in the right chest with the original lead. The explanted generator has been requested for return. Further attempts for info are in progress.

Manufacturer Narrative
Device mfg records were reviewed. Review of mfg records confirmed sterilization for both the generator and lead prior to distribution.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=964260
« Last Edit: November 04, 2011, 05:26:28 AM by dennis100 » Logged
dennis100
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« Reply #2 on: April 12, 2011, 04:38:05 AM »

Event Date 01/01/2007
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Event Description
Initial reporter indicated that the pt had their vns therapy system explanted for infection. Good faith attempts are being made for additional info surrounding the infection event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=975407
« Last Edit: November 04, 2011, 04:57:22 AM by dennis100 » Logged
dennis100
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« Reply #3 on: April 12, 2011, 04:38:43 AM »

Model Number 101
Event Date 01/01/2007
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated a vns patient had "scratched and picked at the scar on the neck, thus getting it infected about a year ago. " good faith attempts to obtain additional information were unsuccessful. Review of dhr confirmed sterilization of both lead and generator prior to shipment.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. Vns labeling lists infection as a possible side effect related to vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1066674

« Last Edit: November 04, 2011, 04:55:22 AM by dennis100 » Logged
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« Reply #4 on: April 12, 2011, 04:40:29 AM »

Event Date 01/01/1998
Event Type Injury Patient Outcome Required Intervention;
Manufacturer Narrative
Murphy jv, hornig gw, schallert gs, tilton cl. Adverse events in children receiving intermittent left vagal nerve stimulation. Pediatr neurol 1998; 19(july):42-4.

Event Description
In review of an article, it was reported that a vns patient developed an abscess around the generator and leads that did not resolve with parenteral antibiotics. The patient had her vns device removed and underwent another 4 weeks of parenteral antibiotics. The vns device was reimplanted 10 days later. Good faith attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1165108
« Last Edit: November 04, 2011, 04:11:05 AM by dennis100 » Logged
dennis100
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« Reply #5 on: April 12, 2011, 04:44:43 AM »

Model Number 303-20
Event Date 11/03/2008
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported that a vns patient had developed a bulge in her neck two months after implant surgery and indicated that pus had discharged from the site. The patient's implanting surgeon related the event to an infection and indicated that the event would be addressed with medication and that no additional surgical interventions would be taken. Good faith attempts for additional information have been unsuccessful to date.

Manufacturer Narrative
Other - device manufacturing records were reviewed. Results - other - review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1252393

« Last Edit: November 04, 2011, 04:08:50 AM by dennis100 » Logged
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« Reply #6 on: April 12, 2011, 04:46:09 AM »

Model Number 103
Event Date 01/06/2011
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported by a surgeon that an infection was found in the chest area while performing generator replacement surgery. The surgeon described the infection as a "bubble infection" in the pocket. The pt was given antibiotics and vns was not re-implanted.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of mfg records confirmed sterilization for both the generator and lead prior to distribution.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1979722

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dennis100
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« Reply #7 on: April 12, 2011, 04:46:54 AM »

Model Number 102
Event Date 11/01/2006
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated a patient had an infection at the vns generator site that was believed to be due to residual abscesses from an infection in 2004. The previous infection was reported via mdr #1644487-2006-00269. The patient later developed another infection with the same vns generator in 2008, which was reported via mdr #1644487-2009-01547. Attempts to the reporter for additional information have been unsuccessful to date.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1419359

« Last Edit: November 04, 2011, 03:38:13 AM by dennis100 » Logged
dennis100
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« Reply #8 on: April 12, 2011, 04:47:38 AM »

Model Number 102
Event Date 03/01/2009
Event Type Injury Patient Outcome Required Intervention;
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was initially reported by the physician that the patient had his vns system explanted due to infection at electrode site. Patient was not treated with antibiotics for this infection. Additional information from the physician revealed that infection was confirmed. Cultures were taken and they grew out to be multiple infections. No patient manipulation or trauma was reported. Sterility records were checked and it was confirmed that the device was sterile at the time of dispatch from manufacture.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1518833

« Last Edit: November 04, 2011, 03:09:31 AM by dennis100 » Logged
dennis100
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« Reply #9 on: April 12, 2011, 04:48:14 AM »

Model Number 102
Event Date 09/10/2008
Event Type Injury Patient Outcome Required Intervention;
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for the generator prior to distribution.

Event Description
It was reported to manufacturer that the vns patient had the generator and a portion of the lead removed due to an infection at the chest incision site. Further follow up with the patient's primary care physician revealed that the patient picked at the chest incision site, which likely contributed to the infection. It was noted that the patient has a history of picking at the incisions. Good faith attempt to obtain additional information from the surgeon have been made, but have been unsuccessful to date. Further follow up with the explanting facility revealed that the explanted devices have been discarded.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1526998
« Last Edit: November 04, 2011, 03:07:41 AM by dennis100 » Logged
dennis100
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« Reply #10 on: April 12, 2011, 04:48:59 AM »

Model Number 102
Event Date 01/01/2008
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
It was reported that the pt had been implanted with vns and had to be explanted, due to infection. No further details are available at this time and the explant date is unk. Attempts for further info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1615706
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dennis100
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« Reply #11 on: April 12, 2011, 04:49:32 AM »

Event Date 02/01/2010
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated that the pt had their device removed due to an infection. No other info was provided regarding the issue. Attempts for further info regarding the issue, and to have the explanted devices returned for analysis, have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1631443
« Last Edit: November 04, 2011, 02:29:49 AM by dennis100 » Logged
dennis100
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« Reply #12 on: April 12, 2011, 04:50:25 AM »

Model Number 102
Event Date 06/29/2010
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported that a patient was admitted to the hospital and placed on antibiotics (iv vancomycin) due to an infection over the generator site that developed approx 7 years after the pt was implanted. Cultures were taken and revealed (b) (6). The infection was over the generator site and the exact cause was unk. There was an abscess over the generator site. The dhr for the lead and generator were reviewed and sterility prior to shipment was confirmed. The lead and generator were both explanted and not replaced.

Manufacturer Narrative
Eval results: review of mfg records confirmed sterilization for both the generator and lead prior to distribution.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1774929

« Last Edit: November 04, 2011, 02:02:40 AM by dennis100 » Logged
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« Reply #13 on: April 12, 2011, 04:50:59 AM »

Model Number 102R
Event Date 02/09/2009
Event Type Injury Patient Outcome Required Intervention;
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
During the review of device records, it was noted that the patient's device was explanted shortly after implant with no known reason. Later, it was determined that the patient's pulse generator was explanted due to an infection. No further details were made on the issue. The manufacturer device history records for both lead and generator were reviewed indicating that the device was sterilized prior to distribution. Good faith attempt to obtain add'l information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1813997
« Last Edit: November 04, 2011, 02:00:45 AM by dennis100 » Logged
dennis100
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« Reply #14 on: April 12, 2011, 04:56:10 AM »

Model Number 103
Event Date 10/01/2010
Event Type Injury Patient Outcome Required Intervention;
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was initially reported by the physician that the pt is scheduled for an explant of generator again. Pt last time was explanted due to infection as well which was reported in mfr report # 1644487-2010-01789. Follow up with the physician's office nurse revealed that the pt had his generator explanted again due to infection at the generator site again after the last re-implantation. Nurse indicated that the pt is large breasted and possibly a sweating issue in that area contributed to the event. Nurse was not sure about any cultures taken or not. No pt manipulation to the site was reported. Explanted generator was returned to manufacturer for analysis. Analysis is currently pending on the returned generator. Device sterility records were checked and confirmed that the device was sterile at the time of dispatch from the facility.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1898025

« Last Edit: November 04, 2011, 01:30:28 AM by dennis100 » Logged
dennis100
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« Reply #15 on: April 12, 2011, 04:56:57 AM »

Model Number 102R
Event Date 09/18/2010
Event Type Injury Patient Outcome Required Intervention;
Manufacturer Narrative
Method - device manufacturing records were reviewed. Results - review of manufacturing records confirmed sterilization for generator prior to distribution.

Event Description
It was initially reported by the company representative the patient's generator was explanted due to infection. The physician felt the infection was related to poor wound healing following surgery. The infection failed to resolve with oral antibiotics. There was no reported trauma or manipulation that may have caused or contributed to the event. Cultures were taken and showed (b)(6) was present. Generator replacement is planned but has not occurred. The dhr for generator was reviewed and sterility prior to shipment was confirmed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1917354

« Last Edit: November 04, 2011, 01:28:30 AM by dennis100 » Logged
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« Reply #16 on: June 19, 2011, 02:03:52 AM »

Model Number 104
Event Date 03/01/2011
Event Type Injury Patient Outcome Required Intervention;
Manufacturer Narrative
Device mfg records were reviewed. Review of mfg records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported by a physician that a vns pt was going to be explanted due to an infection. The pt had been treated with antibiotics over the last couple of weeks, but then developed a seroma. Consequently, the surgeon decided to remove the pt's generator. A review of the generator's design history records showed that it had been sterilized prior to shipping. Info was received from the pt's physician indicating that the infection resulted from the pt's previous generator replacement surgery, and there had been no report of trauma or manipulation. Cultures had been taken which resulted in mrsa.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2088592
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« Reply #17 on: June 22, 2011, 10:48:25 PM »

Event Date 01/01/2003
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Vns therapy system labeling lists infection as a potential adverse event, possibly associated with surgery.

Event Description
Manufacturer received two implant cards, one implant card documented the initial implant of the vns therapy system and the other implant card documented the explant of a generator and the reimplant of another generator and lead. The reason for explant of the generator was not listed. Subsequent information obtained indicated that both generator and lead were replaced due to infection which started at the lead. The cause of infection is unknown. The serial number of lead implanted at the time of the reported infection is unknown at this time and the explanted products will not be returned to cyberonics. Treating physician reports that "the patient is doing very well with new system".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=841834
« Last Edit: November 02, 2011, 10:32:47 AM by dennis100 » Logged
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« Reply #18 on: June 22, 2011, 10:49:30 PM »

Model Number 102
Event Date 04/05/2007
Event Type Injury Patient Outcome Required Intervention;
Manufacturer Narrative
Review of mfg records confirmed sterility of the lead and generator prior to commercial distribution. Vns therapy system labeling lists infection as a potential adverse event, possibly related to surgery.

Event Description
Reporter indicated a pt had developed an infection at the generator site related to recent vns implant surgery. The pt's vns generator and most of the lead were explanted; the patient remains on antibiotics. The pt will be reimplanted as soon as the infection clears. The explanted lead and generator were discarded by the hospital.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=850287

« Last Edit: November 02, 2011, 04:41:57 AM by dennis100 » Logged
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« Reply #19 on: June 24, 2011, 04:39:01 AM »

Model Number 101
Event Date 02/02/2001
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Method: performed analysis of concomitant device. Results: analysis of the concomitant device concluded that it is consistent with conditions that exist after the explant procedure. No anomalies that could have an adverse effect on the device performance were identified.

Manufacturer Narrative
Method: sterilization records reviewed. Conclusions: sterilization process parameters were within specification.

Event Description
Reporter indicated that device was explanted due to infection.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=328347
« Last Edit: November 02, 2011, 04:26:53 AM by dennis100 » Logged
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« Reply #20 on: June 24, 2011, 04:40:18 AM »

Model Number 300-20
Event Date 12/26/2000
Event Type Injury Patient Outcome Hospitalization; Required Intervention Other
Event Description
Infection.

Manufacturer Narrative
H. 6 method - sterilization process records reviewed. H. 6. Conclusion - sterilization process parameters were within specification.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=317981
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« Reply #21 on: June 24, 2011, 04:41:31 AM »

Model Number 100
Event Date 11/24/1999
Event Type Injury Patient Outcome Hospitalization; Required Intervention Other
Manufacturer Narrative
Sterilization processing records reviewed. Sterilization process parameters were within specification.

Event Description
Infection.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=318077
« Last Edit: November 02, 2011, 03:39:07 AM by dennis100 » Logged
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« Reply #22 on: June 24, 2011, 04:42:33 AM »

Model Number 101
Event Date 08/22/2000
Event Type Injury Patient Outcome Hospitalization; Required Intervention Other
Manufacturer Narrative
Sterilization process records reviewed. Sterilization process parameters were within specs.

Event Description
Describe event or problem: infection.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=318110
« Last Edit: November 02, 2011, 03:20:01 AM by dennis100 » Logged
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« Reply #23 on: June 24, 2011, 04:43:45 AM »

Model Number 100
Event Date 03/28/1996
Event Type Injury Patient Outcome Hospitalization; Other Required Intervention
Manufacturer Narrative
Explanted pulse generator and bipolar lead were returned from study site. Follow up with site revealed that devices were explanted due to infection. Pt was reimplanted in 1997.

Manufacturer Narrative
Sterilization processing records reiewed code. Sterilization process parameters were within specification.

Event Description
Infection.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=318368

« Last Edit: November 02, 2011, 02:55:21 AM by dennis100 » Logged
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« Reply #24 on: June 24, 2011, 04:44:59 AM »

Model Number 100
Event Date 12/01/2000
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that device was explanted due to infection.

Manufacturer Narrative
H. 6. Device mfg records were reviewed. H. 6. Review of device mfg records confirmed sterilization of devices. Concomitant device was also returned and analyzed. Continuity check using a multimeter was performed. Continuity check did not identify any discontinuities on the portions of the lead returned. The condition of the lead is consistent with conditions that exist after the explant procedure.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=334259
« Last Edit: November 02, 2011, 02:34:26 AM by dennis100 » Logged
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« Reply #25 on: June 24, 2011, 04:45:54 AM »

Model Number 101
Event Date 02/13/2001
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Method: sterilization records reviewed. Conclusions: sterilization parameters were within specification.

Event Description
Reporter indicated that device was explanted for unknown reason. Further investigation revealed that device was explanted due to infection.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=346233
« Last Edit: November 02, 2011, 02:14:43 AM by dennis100 » Logged
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« Reply #26 on: June 24, 2011, 06:24:29 AM »

Model Number 300-20
Event Date 11/01/2001
Event Type Injury Patient Outcome Required Intervention;
Manufacturer Narrative
A continuity check using a multimeter was performed on the portion of the lead returned. Device mfg records were reviewed. Continuity check did not identify any discontinuities on the portion of the lead returned. The condition of the lead is consistent with conditions that exist after the explant procedure. Review of device mfg records confirmed sterilization of devices.

Manufacturer Narrative
Method: device manufacturing records were reviewed. Results: review of manufacturing records confirmed sterilization of devices. Conclusions: physician believes that the patient was allergic to the surgical glue that was used to close the skin after the implant procedure and hence developed and infection.

Event Description
Reporter indicated that the patient developed an infection after implant surgery. Further follow up revealed that the physician believed that the rash was due to an allergy from the surgical glue that was used to close the skin after the implant procedure. The physician believes that the pt may have had an allergic reaction to the glue and hence developed a skin infection. It was reported that the patient was treated with antibiotics and hot packs. Patient's wound was reported to be healing well at follow up visit with physician (date unknown); however, there was no one small area that still contained purulent matter and signs of infection. An i&d procedure was performed on the wound and a second dose of antibiotics was prescribed. At a later follow up visit (date unknown), the wound still showed signs and symptoms of infection and the lead appeared to be eroding through the skin at the neck site. Vns explant is expected. Attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative
Further follow-up revealed that the infection was treated with antibiotics, i&d, and explant of pulse generator and lead (including electrodes). The physician indicated that re-implant is scheduled (date unknown). H. 6. The physician indicated that the pt has an excessive amount of drooling and that the pt irritated/scratched either incision site. H. 6. The physician indicated that the infection has been resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=378547

« Last Edit: November 02, 2011, 01:52:53 AM by dennis100 » Logged
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« Reply #27 on: June 24, 2011, 07:18:38 AM »

Model Number 101
Event Date 06/19/2002
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated that pt's ncp system was explanted due to infection. The pt was discharged from the hospital following implant surgery in 2002. The following day the pt returned to the hospital with a temperature of 103 degrees. The pt was admitted and treated with iv antibiotics. The pt was reported to have cellulitis at the implant site communicating through the entire tunneling route into the nerve implant site. The infection was determined to be staph aureus. 3 days later the device was explanted and the pt was still hospitalized.

Manufacturer Narrative
Further follow-up revealed that the physician did not use intra-operative antibiotics during the implant procedure as recommended in device labeling.

Manufacturer Narrative
H6 method: device mfg records were reviewed. H6 results: review of mfg records confirmed sterilization of devices.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=407544
« Last Edit: November 02, 2011, 01:23:27 AM by dennis100 » Logged
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« Reply #28 on: June 24, 2011, 08:50:52 AM »

Model Number 101
Event Date 08/01/2002
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
H. 6. Method: device manufacturing records were reviewed. Results: review of manufacturing records for both the pulse generator and the bipolar lead confirmed sterilization of devices.

Event Description
Reporter indicated that patient developed an infection following generator replacement surgery. The replacement generator and the original lead were later explanted. The infection has reportedly resolved. Reimplant is not scheduled at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=418964

« Last Edit: October 19, 2011, 05:50:25 AM by dennis100 » Logged
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« Reply #29 on: June 24, 2011, 10:26:31 AM »

Model Number 101
Event Date 10/01/2002
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
H. 6. Method: device mfg records were reviewed. Results: ncp system labeling lists infection as a potential adverse event associated with surgery. Review of manufacturing records confirmed sterilization for both the pulse generator and the bipolar lead.

Event Description
Patient was hospitalized for treatment of an infection at both the generator and lead sites following vns implant. The treating physician reportedly believed that the patient's body was rejecting the lead and generator. Both the generator and the lead were explanted. The patient has fully recovered and the infection is resolved. A re-implant is not scheduled at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=429435

 
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