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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 06/30/2009
Event Type  Malfunction  
Event Description

Neurology reported their pt was complaining of pain in the left neck area that seemed to be an electrical type of buzz. The pt reported that it was a near daily occurrence lasting a brief number of seconds. If the pt pushed up on the soft tissue under her left mandible she could decrease the symptoms. The pt was also having an aura- like symptoms around the same time as her pain events. Diagnostics were performed and confirmed proper device function (systems: ok/ok/2/no; normal mode: ok/ok/3/no). It was planned to send the pt for revision since they had been implanted approx 6 years and for pt comfort related to their pain events. The pt's surgeon was concerned there was "some type of malfunction. " neurology confirmed device function and device to be "in working order. " the pt had full revision surgery and the explanted products are at the mfr pending completion of product analysis. The return product form documented the pt had a lead break. X-rays were reviewed prior to surgery that showed no device anomalies in the images available, though the presence of the pt's previous lead and surgical staples was identified. The x-rays confirm the presence of an adequate strain relief bend and the absence of a strain relief loop. Two tie-downs appeared to have been utilized, though both were used to secure the strain relief bend in place.

 
Manufacturer Narrative

Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized. Device malfunction 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 Key1583752
Report Number1644487-2010-00066
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/15/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/13/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2006
Device MODEL Number302-20
Device LOT Number010657
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer12/29/2009
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/15/2009
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/01/2004
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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