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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 03/07/2011
Event Type  Injury  
Event Description

It was reported that the vns patient had his lead and generator explanted due to infection at the generator site. Cultures had been taken on (b)(6) 2011 that indicated (b)(6). No trauma or manipulation was reported. The surgeon's office stated that the wound had dehisced and the generator could be seen inside the wound. No medication changes were made precluding the wound dehiscence. The patient is currently reported as healing well. Review of the device history record confirmed sterility of the lead and generator prior to being shipped from the manufacturer.

 
Manufacturer Narrative

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

 
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Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key2077810
Report Number1644487-2011-00864
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/23/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/21/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2012
Device MODEL Number103
Device LOT Number201586
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/23/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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