• 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 03/01/2010
Event Type  Malfunction  
Event Description

It was initially reported by the surgeon that the pt was taken into surgery for battery replacement due to end-of-service (eos). Surgeon also indicated that the device was turned off as pt was experiencing stabbing pain at the generator site. When pt was taken into surgery, preop diagnostics on the device showed high lead impedance and not eos. Diagnostics were performed twice and same results were obtained. The surgeon decided to replace the generator and the lead. Pt's neck was opened and the surgeon was able to visualize a complete lead break near the bifurcation of the old lead. New generator and lead were placed in the pt and post-op diagnostics showed everything working within normal limits. The surgeon accidentally nicked the left intra-jugular vein during surgery. A vascular surgeon was called to repair the vein and pt was closed up. No x-rays were taken prior to the surgery. Painful stimulation at the generator is likely related to the high lead impedance. Good faith attempts to obtain add'l info has been unsuccessful.

 
Manufacturer Narrative

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
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1659924
Report Number1644487-2010-00860
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/09/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/08/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2006
Device MODEL Number302-20
Device LOT Number10489
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer03/18/2010
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/09/2010
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/01/2004
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/08/2010 Patient Sequence Number: 1
-
-