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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 01/01/2010
Event Type  Malfunction  
Event Description

During generator replacement surgery due to generator battery depletion, when the new generator was connected to the existing lead, high lead impedance resulted. The surgeon opened the neck incision to explore the cause of the high lead impedance, and it was noted by the surgeon that "one of the electrodes was detached from the nerve and there was also a lead fracture. " the lead was subsequently explanted and a new lead was implanted. The explanted lead and generator were discarded after the surgery, and are therefore not available to be returned to manufacturer for additional analysis. Further follow up with the treating physician revealed that the last diagnostic test was done in (b) (6)2009, which revealed normal device function. The device was not able to be interrogated at subsequent follow up visits that took place in (b) (6)2009, and again in (b) (6)2010 prior to surgery, which was believed to be due to battery depletion. There were no x-rays taken prior to surgery to assess the continuity of the device.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to 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 Key1619798
Report Number1644487-2010-00474
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/28/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/26/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2006
Device MODEL Number302-20
Device LOT Number11652
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/28/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2004
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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