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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 01/01/2009
Event Type  Malfunction  
Event Description

It was initially reported by the site that the pt was taken into surgery for implanting a nerve stimulator. Pt is implanted with vns and after the implant of nerve stimulator, the surgeon noticed high lead impedance on system diagnostics. X-rays were taken and sent to mfr for review. The improper connector pin insertion is most likely contributing to the high lead impedance. However, a lead discontinuity on the portions of the lead body that could not be assessed cannot be ruled out. The electrodes were also placed inverted on the vagus nerve. No manipulation or trauma was reported and pt showed increase in seizures in the past week or so. Good faith attempts to obtain additional info have been unsuccessful till date.

 
Manufacturer Narrative

Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized. Device failure is confirmed, but did not cause or contribute to a death. The improper lead pin, connector pin is the likely cause of the high lead impedence.

 
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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 Key1658414
Report Number1644487-2010-00883
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/11/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/09/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2013
Device MODEL Number302-20
Device LOT Number201101
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/11/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2009
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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