• 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. BIPOL LEAD MODEL 300

  • 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. BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Event Date 01/01/2009
Event Type  Malfunction  
Event Description

It was reported that a vns patient was experiencing neck pain with stimulation, and diagnostic testing resulted in high lead impedance. Vns was programmed off. Good faith attempts to obtain additional information have been unsuccessful to date. Full revision surgery is likely.

 
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 NameBIPOL LEAD MODEL 300
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1315537
Report Number1644487-2009-00292
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/23/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/13/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2003
Device MODEL Number300-20
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/23/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2001
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-