• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 04/25/2008
Event Type  Malfunction  
Event Description

Mfr received pa and lateral chest and left neck x-rays from the treating physician to review the integrity of the lead. The physicians notes regarding the x-rays stated that there was no lead breaks observed and the sys appeared intact. Review of x-rays by the mfr revealed no obvious lead discontinuities or anomalies. The lead pin was fully inserted in to the generator, but was not able to be visualized past the connector block. Further follow up with the treating physician revealed that the pt had surgery recently to remove cysts on the posterior neck region, and that the pt has lennox-gastaut syndrome, static encephalopathy, and medically intractable epilepsy. Additionally, it was noted at a recent follow up visit, a sys diagnostic test revealed high lead impedance. Attempts to obtain add'l info from the treating physician are underway. Revision surgery is likely.

 
Manufacturer Narrative

Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized. Conclusions - device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEAD MODEL 302
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
michael carroll
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1059781
Report Number1644487-2008-01348
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 05/16/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/11/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2006
Device MODEL Number302-20
Device LOT Number011003
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/16/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2004
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-