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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 02/28/2011
Event Type  Malfunction  
Event Description

It was reported that the vns patient was experiencing painful stimulation in her abdomen. The patient's generator was implanted in the abdomen due to her small size. Diagnostics of the vns were performed at the patient's next visit that indicated high impedance. The physician was advised to disable the patient's vns; however, the physician chose to leave the stimulation enabled. It was noted that the patient has grown 7 inches since her initial vns implant. Surgery to replace the patient's vns lead and generator has occurred. When the lead was explanted, the lead was noted to be fractured. Attempts for the return of the explanted lead and generator have been unsuccessful to date. Attempts for further information have been unsuccessful to date.

 
Manufacturer Narrative

Device failure occurred but did not cause or contribute to a death or serious injury.

 
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Brand NameLEAD MODEL 302
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key2118871
Report Number1644487-2011-01223
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/03/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/02/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2008
Device MODEL Number302-20
Device LOT Number1501
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/03/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2006
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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