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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103

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CYBERONICS, INC. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 08/17/2012
Event Type  Injury  
Event Description

The patient's explanting surgeon reported to the patient's mother that at the time of explant it was noted that there was a lot of scarring and thin, loose skin around the device, probably causing the patient to feel some pain since not enough fat to insulate the device. The patient did not report any pain events prior to their explant event. Prior to explant in (b)(6) 2012, the patient was having coughing and dysphagia with stimulation. The patient's surgeon reported that their explant was more related to a rejection to the implanted products not an infection. It was reported that the vns seemed to reduce the patient's seizures as was reported to have had only 1 big seizure (b)(6) 2012. The patient was having seizures again since their device was explanted. No further information has been received at this time.

 
Event Description

Additional information was received. The patient's surgeon reported that their explant was more related to a rejection to the implanted products, not an infection. It is possible that picking at the wound led to the eventual dehiscence, but the exuberant tissue overgrowth was likely the main problem and not related to the trauma or manipulation. Cultures were taken from the neck incision when the vns was explanted on (b)(6) 2012. They grew out staph aureas. The patient was treated with antibiotics starting (b)(6) 2012 and the extruded neck lead was reimplanted after re-exploration and thorough irrigation on (b)(6) 2012. Their infection has resolved. At this time they do not plan to re-implant it since i believe the patient's hypertrophic reaction is a rejection to the device material.

 
Event Description

A vns patient reported that they had their generator and lead explanted for an infection at the electrode site. The family wants device replaced if possible once their infection heals. Thus far no further information has been attained.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Describe event or problem: omitted off initial report.

 
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Brand NamePULSE GEN MODEL 103
Type of DevicePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2794269
Report Number1644487-2012-02646
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup,Followup
Report Date 09/21/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/17/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2013
Device MODEL Number103
Device LOT Number201958
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received11/20/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/22/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/17/2012 Patient Sequence Number: 1
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