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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 08/01/2009
Event Type  Malfunction  
Event Description

It was reported to mfr that the vns pt began experiencing a recent onset of painful stimulation in the chest and abdominal area, which occurred erratically, not with every stimulation cycle. Additionally, there was report of an increase in seizures activity, below the pre-vns baseline. Both system and normal mode diagnostic tests were preformed following the onset of the reported event and revealed normal device function. The physician believes that there is a device issue, and has referred the pt for surgery to replace the lead and the generator. X-rays were taken and sent to mfr for review where there were no gross lead discontinuities observed, and there were no other obvious anomalies visualized which could be contributing to the events. There was no report of trauma or manipulation of the device prior to the onset of the reported events, however, the mother reports that the pt is a "rowdy kid".

 
Manufacturer Narrative

Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized. Device failure is suspected, 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 Key1510635
Report Number1644487-2009-02218
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/03/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/02/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2005
Device MODEL Number302-20
Device LOT Number009063
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/03/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2003
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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