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dennis100
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« Reply #30 on: June 24, 2011, 11:23:14 AM »

Model Number 102
Event Date 12/30/2002
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
H. 6. Additional method code: device manufacturing records were reviewed. H. 6. : review of manufacturing records for both the pulse generator an the bipolar lead confirmed sterilization of devices. Ncp system labeling lists infection as a potential adverse event possibly associated with surgery. Patient reportedly irritated/scratched at incision site. The infection has reportedly resolved.

Event Description
Reporter indicated that pt's ncp system was explanted due to infection in the pulse generator/pocket area. No cultures were performed. The pt reportedly irritated/scratched at the incision site. The infection was treated with antibiotics and explant of the pulse generator and lead (leaving electrodes). The pt's device was reportedly implanted in the posterior scapula area. No re-implant is scheduled at this time. The infection has reportedly resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=443585
« Last Edit: October 19, 2011, 04:43:47 AM by dennis100 » Logged
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« Reply #31 on: June 24, 2011, 12:29:51 PM »

Model Number 100
Event Date 12/27/2002
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
H. 6. Device mfg records were reiviewed. Review of mfg records for both the pulse generator and the bipolar lead confirmed sterilization of devices. Ncp system labeling list infection as a potential adverse event possibly associated with surgery. It was reported that the pt irritated/scratched the incision sites.

Event Description
Pt was explanted due to infection. It was reported that the infection was present at both the pulse generator/pocket and bipolar lead/cervical areas. It was reported that the pt had a superficial infection and was treated with antibiotics for 3 months and debridement of the site. The pt reportedly irritated/scratched the incision sites. The ncp system was later explanted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=456253

« Last Edit: October 19, 2011, 04:24:39 AM by dennis100 » Logged
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« Reply #32 on: June 25, 2011, 01:54:24 AM »

Model Number 302-20
Event Date 04/01/2003
Event Type Injury Patient Outcome Required Intervention;
Manufacturer Narrative
Report is incomplete because an attempt to obtain additional information has been unsuccessful to date. No response has been received to manufacturer's request for additional information from treating neurologist. H. 6. Device manufacturing records were reviewed. Vns therapy labeling lists infection as a potential adverse event possibly associated with surgery. Review of manufacturing records for both the pulse generator and the bipolar lead confirmed sterilization of devices. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to anti epileptic medications. In the united states, the vns therapy system is approved for use in adults and adolescents over 12 years of age with partial onset seizures that are refractory to anti epileptic medications.

Event Description
Reporter indicated that patient had developed an infection at the neck site and the site had to be resutured. It was reported that the sutures were removed and the patient is scheduled for a follow-up visit with neurosurgeon to assess whether or not explant is required.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=461924

« Last Edit: October 18, 2011, 11:34:43 PM by dennis100 » Logged
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« Reply #33 on: June 25, 2011, 01:55:04 AM »

Model Number 302-20
Event Date 06/04/2003
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Report is incomplete because attempts to obtain additional info have been unsuccessful to date. No response has been rec'd to mfr's requests for additional info from treating neurosurgeon. Product analysis results will not change the conclusion of the reported infection because explanted products are decontaminated prior to return; therefore, microbiological testing is not performed. In the event that the device is explanted and returned, product analysis results will only be reported if a device malfunction is noted that would be likely to cause a death or serious injury if the malfunction were to recur. H. 6. Device mfg records were reviewed. Vns therapy labeling lists infection as a potential adverse event possibly associated with surgery. Review of mfg records for both the pulse generator and the bipolar lead confirmed sterilization of devices. The pt reportedly picked at the incision site and pulled a portion of the lead out through the incision.

Event Description
Reporter indicated that a portion of pt's lead was protruding from the incision site. Revision surgery was performed during which the exposed portion of the lead was placed back into the pocket. There were no signs of infection. Further follow-up revealed that the pt had picked at the incision site, and had pulled a part of the lead out through the incision. Following the revision surgery, the pt had again picked at the incision site and had again pulled a portion of the lead out through the incision. It was then reported that the pt had a staph infection at the generator site. The pt was seen by a different surgeon who covered the site with tegaderm and treated with bactroban ointment until the pt could be seen by their regular surgeon who was out of town at the time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=468565

« Last Edit: October 18, 2011, 11:14:15 PM by dennis100 » Logged
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« Reply #34 on: June 25, 2011, 07:22:41 AM »

Model Number 101
Event Date 07/14/2003
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Product analysis results will not change the conclusion of the reported infection because explanted products are decontaminated prior to return; therefore, microbiological testing is not performed. In the event that the explanted device is returned, product analysis results will only be reported if a device malfunction is noted that would be likely to cause a death or serious injury if the malfunction were to recur. H6: ncp system labeling lists infection as a potential adverse event possibly associated with surgery. Review of mfg records for the pulse generator confirmed sterilization of the device.

Event Description
Reporter indicated that vns pt had developed an infection at the pulse generator/pocket area. The infection was treated with antibiotics and explant of the pulse generator only. It was reported that the infection had resolved and that reimplant is not scheduled at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=478545
« Last Edit: October 18, 2011, 10:51:35 PM by dennis100 » Logged
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« Reply #35 on: June 25, 2011, 07:24:21 AM »

Model Number 102
Event Date 08/01/2003
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional info from treating neurologist. Product analysis results will not change the conclusion of the reported event because explanted products are decontaminated prior to return; therefore, microbiological testing is not performed. In the event that the explanted device is returned, product analysis results will only be reported if a device malfunction is noted that would be likely to cause a death or serious injury if the malfunction were to recur. Vns therapy system labeling lists infection as potential adverse event possibly associated with surgery. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy system is approved for use in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications.

Event Description
Reporter indicated that vns pt was explanted due to infection.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=488323
« Last Edit: October 18, 2011, 12:41:40 PM by dennis100 » Logged
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« Reply #36 on: June 25, 2011, 08:43:04 AM »

Model Number 302-20
Event Date 12/01/2003
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Further follow-up revealed that the pt underwetn explant of pulse generator and hipolar lead due to infection. H. 6. Code 200: pt reportedly irritated/scratched at incision site.

Manufacturer Narrative
Product analysis results will not change the conclusion of the reported event because explanted products are decontaminated prior to return; therefore, microbiological testing is not performed. In the event that the device is explanted and returned, product analysis results will only be reported if a device malfunction is noted that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. H. 6. Device mfg records were reviewed. Vns therapy system labeling lists infection and foreign body reaction to implants, including possible tumor formation as potential adverse events possibly associated with surgery or stimulation. Review of mfg records for both the pulse generator and the bipolar lead confirmed sterilization of devices.

Event Description
Reporter indicated that vns pt developed an infection at the neck incision site. It was reported that the pt went to the hosp emergency room because they were experiencing "irritation" at the neck incision site. The e. R. Physician "sliced open" the incision because he felt the lead wires underneath the skin and did not know what they were. The pt was sent home from the emergency room with the wound open. The pt was later seen by implanting neurosurgeon who reportedly removed the tie-downs and sutured the wound closed. Neurosurgeon prescribed a two-week course of antibiotics. Neurosurgeon indicated that he believed that the tie-downs were irritating the tissue and creating infection and that he would try to place them deeper when performing future implants.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=505053

« Last Edit: October 18, 2011, 12:26:04 PM by dennis100 » Logged
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« Reply #37 on: June 25, 2011, 09:56:49 AM »

Model Number 102
Event Date 02/24/2004
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Product analysis results will not change the conclusion of the reported event because explatned products are decontaminated prior to return; therefore, microbiological testing is not performed. In the event that the device is explanted and returned, product analysis results will only be reported if a device malfunction is noted that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. H. 6. Vns therapy system labeling lists infection as a potential adverse event possibly associated with surgery. Review of manufacturing records for both the pulse generator and the bipolar lead confirmed sterilization of devices. H. 6. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy system is approved for use in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications.

Event Description
Reporter indicated that vns pt developed an apparent infection at the generator site. The infection was treated with antibiotics and i&d and has not yet resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=518044
« Last Edit: October 18, 2011, 12:10:42 PM by dennis100 » Logged
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« Reply #38 on: June 27, 2011, 11:27:26 AM »

Model Number 100
Event Date 01/01/2000
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Product analysis results will not change the conclusion of the reported event because explanted products are decontaminated prior to return; therefore, microbiological testing is not performed. In the event that the explanted device is returned, product analysis results will only be reported if a device malfunction is noted that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. H. 6. Ncp system labeling lists infection as a potential adverse event possibly associated with surgery. Review of manufacturing records for both the pulse generator and the bipolar lead confirmed sterilization of devices.

Event Description
Reporter indicated that vns pt was explanted due to infection. It was reported that only the pt's generator was explanted. The infection was treated with iv antibiotics. The infection resolved and the pt was reimplanted with a new generator approximately 7 months later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=531011

« Last Edit: October 18, 2011, 01:04:13 AM by dennis100 » Logged
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« Reply #39 on: June 27, 2011, 11:28:20 AM »

Model Number 102
Event Date 06/07/2004
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Product analysis results will not change the conclusion of the reported event because explanted products are decontaminated prior to return; therefore, microbiological testing is not performed. In the event that the device is explanted and returned, product analysis results will only be reported if a device malfunction is noted that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Vns therapy labeling lists infection as a potential adverse event possibly associated with surgery.

Event Description
Reporter indicated that vns pt was hospitalized for 3 days approx two weeks post-implant due to staph infection at the generator site. Treating neurosurgeon indicated that the pt had irritated/scratched at the incision site and that the infection was treated with antibiotics. The infection has reportedly resolved. Review of mfg records for both the pulse generator and the bipolar lead confirmed sterilization of devices.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=538479
« Last Edit: October 18, 2011, 12:39:38 AM by dennis100 » Logged
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« Reply #40 on: June 29, 2011, 01:05:19 PM »

Model Number 101
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that the pt underwent generator explant due to infection. It was also reported that the infection has not yet resolved. The pt has been referred to an infectious disease physician because the pt has been developinhg sores on their arms and legs. Epileptologist is unsure if there is any underlying medical condition that is causing the infections.

Manufacturer Narrative
H. 6. Ncp system labeling lists infection as a potential adverse event possibly associated with surgery. Product analysis results will not change the conclusion of the reported event because explanted products are decontaminated prior to return; therefore, microbiological testing is not performed. In the event that the explanted device is returned, product analysis results will only be reported if a device malfunction is noted that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=547937

« Last Edit: October 17, 2011, 10:31:13 PM by dennis100 » Logged
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« Reply #41 on: June 29, 2011, 01:06:06 PM »

Model Number 102
Event Date 11/24/2004
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requests for additional info from treating neurologist. Product analysis results will not change the conclusion of the reported event because explanted products are decontaminated prior to return; therefore, microbiological testing is not performed. In the event that the device is explanted and returned, product analysis results will only be reported if a device malfunction is noted that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. H. 6: vns therapy system labeling lists infection as a potential adverse event possibly associated with surgery. Additionally, device labeling lists heart rate rhythm changes, device (generator and/or lead) migration/extrusion and neck pain as potential adverse events possibly associated with surgery or stimulation. H. 6. Vns therapy system labeling states that the safety and efficacy of this therapy have not been systematically established for use in pts with history of cardiac arrhythmias or other abnormalities.

Event Description
Reported indicated that pt developed an infection at the incision site after vns implant surgery. Oral antibiotics wre prescribed. Additionally, the pt noticed problems with heart arrhythmia when stimulation was initiated two weeks post-op. The pt also indicated that the device caused depression during stimulation cycles and that the generator has migrated sideways, resulting in a "heavy feeling" and neck pain requiring vicodin. The device was subsequently programmed to off approximately three weeks after stimulation was initiated; however, the pt thinks pt still feels stimulation. The pt was seen for explant consultation by neurosurgeon who reportedly called pt a "baby" and indicated that he would not explant the vns therapy system and that the pt should simply have the device programmed to a lower setting. Treating neurologist reportedly indicated that the pt "is very sensitive to things" and that the pt still wanted to have the vns therapy system explanted. Review of manufacturing records for both the pulse generator and the bipolar lead confirmed sterilization of devices. Investigation to date has been unable to determine the cause of the reported events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=571541

« Last Edit: October 17, 2011, 10:07:08 PM by dennis100 » Logged
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« Reply #42 on: June 30, 2011, 05:21:36 AM »

Model Number 102
Event Date 06/23/2005
Event Type Death Patient Outcome Death;
Event Description
Reporter indicated that vns pt went into a coma and subsequently died. Cause of death was reported to be anoxic brain injury and sepsis, the cause of the coma is unknown; however, it was reported that just prior to the coma, the pt's overall health had been declining. The vns therapy system was not explanted. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance. There is no evidence at this time that the vns therapy system caused or contributed to the reported event.

Event Description
Further follow-up revealed that the patient died while hospitalized. The death certificate listed the immediate cause of death as asystole due to (or a consequence of ) respiratory failure. An autopsy was not performed.

Manufacturer Narrative
H. 6. Vns therapy system labeling cautions that patients with obstructive sleep apnea (osa) may have increased apneic events during stimulation. Cyberron os recommends care when treating patients with preexisting osa. Lowering stimulus frequency or prolonging off time may prevent exacerbation of osa.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=622464
« Last Edit: October 18, 2011, 01:46:33 AM by dennis100 » Logged
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« Reply #43 on: June 30, 2011, 08:54:55 AM »

Model Number 102
Event Date 08/19/2005
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention Manufacturer Narrative
H. 6 - vns system labeling lists infection as a potential adverse event possibly associated with surgery. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications.

Event Description
The reporter indicated that the patient has been hospitalized for a month and is in the icu, trached, moribund, and with do not resuscitate orders. The reporter stated that the patient has infections and wound dehiscence at the vns sites and in her portacath site. The patient had a portacath placed at the time of implant. The patient's family member failed to inform the physician prior to the surgery that the patient has antibotic-resistant bacteria. The vns device was turned on. Manufacturing records were reviewed and sterilization was confirmed for both the pulse generator and lead. The event was likley caused by the patient's pre-existing disease with the vns system or portacath contributing.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=643518

« Last Edit: October 17, 2011, 01:29:32 AM by dennis100 » Logged
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« Reply #44 on: July 01, 2011, 12:39:22 AM »

Model Number 102
Event Date 04/01/2005
Event Type Injury Manufacturer Narrative
Product analysis results will not change the conclusion of the reported event because explanted products are decontaminated prior to return; therefore, microbiological testing is not performed. In the event that the explanted device is returned, product analysis results will only be reported if a device malfunction is noted that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. H. 6: vns therapy system labeling lists infection as a potential adverse event possibly associated with surgery. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy system is approved for use in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications.

Event Description
Reporter indicated that patient underwent vns therapy system explant due to infection. Both the lead and generator were explanted. The infection reportedly resolved and the patient has been reimplanted. Report is incomplete because treating neurologist only partially responded to manufacturer's request for additional information.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=651821

« Last Edit: October 16, 2011, 01:07:05 PM by dennis100 » Logged
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« Reply #45 on: July 01, 2011, 10:35:11 AM »

Model Number 102
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Product analysis result will not change the conclusion of the reported event because explanted products are decontaminated prior to return: therefore. Microbiological testing is not performed. Additionally product analysis is not a required element for the investigation of an infection event as the occurrence of infection is not believed to be related to the device involved, but instead to either the surgical procedue or to patient manipulation of the implant site sterilization was confirmed for both the lead and the generator. Vns therapy system labeling lists infection as a potential adverse event possible associated with surgery.

Event Description
Reporter indicated that patient was explanted due to recurrent infections. During the explant procedure, a large amount of sanguinous material was aspirated from the pulse generator pocket. Both the lead and generator were explanted, after which the wound cavities in both the chest and neck were debrided of granulation tissue.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=702829

« Last Edit: October 16, 2011, 12:02:13 PM by dennis100 » Logged
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« Reply #46 on: July 01, 2011, 10:36:21 AM »

Model Number 102
Event Date 02/22/2006
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Product analysis results will not change the conslusion of the reported event because explanted products are decontaminated prior to return; therefore, microbiological testing is not performed. In the event that the explanted device is returned, product analysis results will only be reported if a device malfunction is noted that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. H. 6. Vns therapy system labeling lists infection as a potential adverse event, possibly associated with surgery. H. 6. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 yrs of age with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy system is approved for use in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications. Treating physician believes that the infection is related to the surgical procedure.

Event Description
Pt underwent generator explant surgery due to infection at the chest incision site. It was reported that the chest incision site did not heal property after implant and that there were several pus pockets around it. The infection was initially treated with antibiotic therapy, after which it reportedly seemed to be improving. The infection then recurred, resulting in explant surgery and i&d. Only the pulse generator was explanted. The pt had reportedly irritated/scratched at the incision site. At the time of initial implant surgery, both preoperative and intraoperative antibiotics were utilized. The vns therapy system tunneling tool was used as a single-use-only device during the procedure. The pt had not undergone any other surgical or dental procedures or invasive monitoring either three months pre or post vns implant surgery; however the pt is also implanted with a ventriculoperitoneal shunt. Treating physician indicates that the event is believed to be related to the surgical procedure. The infection has reportedly resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=727959

« Last Edit: October 16, 2011, 11:44:48 AM by dennis100 » Logged
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« Reply #47 on: July 01, 2011, 10:37:38 AM »

Model Number 302-20 
Event Date 08/06/2006
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Manufacturing records for both the pulse generator and lead were reviewed. Sterilization confirmed before distribution. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 yrs of age with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy system is approved for use in adults and adolesecents over 12 yrs of age with partial onset seizures that are refractory to antiepileptic medications.
Event Description
Reporter indicated pt had vns system explanted for infection. Pt did not have their vns system replaced. Explanted product has been returned to cyberonics for analysis and the analysis has been completed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=758168
« Last Edit: October 16, 2011, 11:26:23 AM by dennis100 » Logged
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« Reply #48 on: July 01, 2011, 10:39:23 AM »

Model Number 102
Event Date 03/20/2007
Event Type  Injury   Patient Outcome  Hospitalization; Required Intervention 
Event Description 
Reporter indicated that patient experienced wound infection and dehiscence at the generator incision site one week following implantation surgery. The physician stated that it was a "straightforward wound infection and he did not notice an infection of the device. " the wound was cleaned and reclosed. Good faith attempts to gain additional information have been unsuccessful to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=843012

« Last Edit: October 16, 2011, 12:26:07 AM by dennis100 » Logged
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« Reply #49 on: July 07, 2011, 01:52:49 AM »

Model Number 102R
Event Date 02/24/2006
Event Type  Injury    
Event Description  
It was initially reported by a physician's office that the pt had their generator moved as "she had picked at it down to the device". The device had not been replaced at this time, and the leads were left intact. Later info indicated that the pt would not like the vns implant any longer; furthermore, the site had reportedly becomes infected prior to its explant. F/u with the physician revealed that the pt had always been a "picker" and she had exposed the device by her picking. However, the physician stated, the extrusion was not related to vns at this time. A review of the mfr's design history records indicated that both the leads and the generator were properly sterilized prior to shipping. The generator was returned to the mfr for analysis and was found to have no sharp edges or other surface anomalies. The pulse generator was found to be operating within designed limits.
 
  
Manufacturer Narrative  
Analysis of labeling performed. 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=2141192
 
« Last Edit: October 15, 2011, 11:27:35 PM by dennis100 » Logged
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« Reply #50 on: August 25, 2011, 01:40:59 AM »

Event Date 06/18/2011
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Event Description
On (b)(6), 2011, the vns implanting surgeon reported that the vns pt had his vns explanted on (b)(6), 2011 due to an (b)(6) infection. They were unaware of any plans to replace it. The surgeon's nurse reported that the vns pt went to the er on (b)(6), 2011 for swelling and pain of the incision sites on the neck and chest. The pt was then placed on oral antibiotics. On (b)(6), 2011, the pt saw their surgeon and the infection has not gotten any better since their er visit two days prior. The surgeon prescribed stronger antibiotics and explained to the pt that if they don't feel better in 12-24 hrs, to visit the surgeon again. The pt was hospitalized on (b)(6), 2011 for the infection and placed on iv antibiotics of vancomycin and aosyn. Cultures of both sites were taken at that time and the infection was discovered to be (b)(6). The pt was explanted on (b)(6), 2011 because of the infection. The surgeon's nurse reported that it is unclear at this time if the infection is related to the vns device or a problem with the surgery. The pt is very alert and did not touch or scratch the site and no trauma was noted that could have caused/contributed to the infection. Review of the mfg records confirmed sterilization for both the generator and lead prior to distribution. If further info is received, it will be reported.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2180925

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dennis100
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« Reply #51 on: August 25, 2011, 01:41:43 AM »

Event Date 04/18/2011
Event Type Injury Patient Outcome Life Threatening; Hospitalization
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 that the pt's caretaker has noticed some redness around the incision site. After her last office visit on (b)(6), 2011, she was admitted to the hospital for cellulitis related to her recent vagal nerve stimulator implantation. The incision site of her vagal nerve stimulator was erythematous. Attempts for further info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2181386
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dennis100
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« Reply #52 on: August 25, 2011, 01:42:57 AM »

Event Date 05/04/2011
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 neurosurgeon that a pt's generator and lead were being explanted due to infection. Mfr performed review of device history records and confirmed sterility of the generator and lead before distribution. However, pt's date of birth is unk and good faith attempts to obtain more info have been unsuccessful to date. The generator and lead were returned to mfr and lead analysis was complete. Majority of the lead assembly (body) including the electrodes was not returned for analysis. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pin at one point in time. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2175671

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dennis100
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« Reply #53 on: August 25, 2011, 01:43:51 AM »

Event Date 05/01/2011
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 neurosurgeon that a vns pt developed an infection at the generator site. The pt's infection developed sometime in (b)(6) 2011. The surgeon washed out the wound and it was healing. However, pt manipulated the generator site and infection reoccurred. The generator and most of the lead were explanted on (b)(6) 2011. Cultures were taken and the infection was confirmed to be mrsa.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2175672

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dennis100
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« Reply #54 on: August 25, 2011, 01:44:30 AM »

Event Date 01/01/2011
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported that the pt had previously had his vns removed due to an infection and was now going to be re-implanted. Both the lead and generator were removed due to the infection. Attempts for additional info on the infection have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2167112
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dennis100
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« Reply #55 on: August 25, 2011, 01:45:16 AM »

Event Date 06/24/2011
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported by a company representative that a vns patient experienced an infection after implantation of the stimulator. The information was provided by a neurosurgeon who indicated the infection was confirmed by a blood sample. The surgeon's interventions included antibiotic treatment inside the chest pocket and move the generator to a new pocket in the chest. The physician believes the event is related to vns surgery. Additional information was received through a company representative indicating that definite cultures were not provided by the surgeon. Moreover, the reported infection seems to have resolved with the treatment of antibiotics and re-positioning of the generator on another chest pocket. However, the surgeon indicated the infection started on the chest where the stimulator was implanted and before second surgery and antibiotic treatment, patient had some reaction up towards the neck, but only a little. At the moment the patient is doing well and the infection has cleared. No further interventions are planned.

Manufacturer Narrative
Method: device manufacturing records were reviewed. Results: 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=2166890

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dennis100
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« Reply #56 on: August 25, 2011, 01:46:02 AM »

Event Date 06/14/2011
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
On (b)(6), 2011,a vns implanting surgeon reported that the vns pt was having their generator explanted that day due to an infection. The pt was gardening when his incision on the chest popped out and he developed an infection at the generator site. After surgery,the chest incision site was to be irrigated with antibiotics for 30 days and then a re-implant would be scheduled. On (b)(6), 2011,the surgeon reported that he has seen the pt twice since surgery and the pt has been doing great. The pt has another appointment later in (b)(6) and then will be scheduled for re-implant surgery. The surgeon also reported that the infection occurred because the pt had dirty hands and picked at his incision. The explanted generator was returned for product analysis that completed on (b)(6), 2011. Results of diagnostic testing indicated the device was operating properly. Electrical test results showed that the pulse generator performed according to functional specifications and there were no adverse functional, mechanical, or visual issues identified with the returned generator. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. If additional info is received, it will be reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2166895

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dennis100
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« Reply #57 on: August 25, 2011, 01:46:43 AM »

Event Date 01/01/2011
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Event Description
Our distributor in (b)(4) received a report that a vns pt had their device explanted for an infection. Good faith attempts are underway for further details about the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2162069
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dennis100
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« Reply #58 on: August 25, 2011, 01:47:29 AM »

Event Date 06/04/2011
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Event Description
It was reported to our distributor in (b)(4) that there was a vns pt who has an infection. It was reported that the parents noticed that pt's left neck skin became red and swollen. The swelling extended to thorax. The pt had an operation on (b)(6) 2011 to drain the pus, in addition to antibiotic medication therapy. They had a total of 5 surgeries to drain pus. The diagnosis is (b)(6) infection, antibiotic resistant bacterial infection. The infection condition has not resolved and a decision to remove the generator and lead has been made. The pt's physician does not think their infection was vns related. The infected wound he suspects from mosquito bite, which pt scratched and had an open wound.

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=2160568
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dennis100
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« Reply #59 on: August 25, 2011, 01:48:12 AM »

Event Date 06/21/1998
Event Type Injury Patient Outcome Required Intervention;
Manufacturer Narrative
Method: device mfg records were reviewed. Results: review of mfg records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported by a neurologist that a vns pt developed an cellulitis infection at the generator site. The generator and lead were explanted on (b)(6) 1998. There was no report of trauma or manipulation. Mfr records confirmed sterilization of both generator and lead prior to distribution. Both generator and lead were returned to mfr and underwent product analysis. Generator met mfr's electrical test specifications. No anomalies were detected or identified that could have any adverse effect on device performance. The lead was returned in several pieces and electrode ribbon was disturbed but was not clear if it occurred during implant or explant procedure. The marked connector was torn from bifurcation; however, continuity check revealed no discontinuities.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2155990

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