• 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 01/13/2015
Event Type  Malfunction  
Event Description

It was reported that device diagnostics resulted in high impedance. It was reported that the patient had recently undergone generator replacement and that device diagnostics prior to generator replacement were within normal limits. X-rays were taken and reportedly did not identify any discontinuities with the vns system. It was reported that the x-rays would not be sent to manufacturer for review. The patient was referred for surgery. The patient underwent surgery on (b)(6) 2015. The lead pin was removed and then reinserted into the generator header. Device diagnostics again resulted in high impedance. The surgeon then replaced the generator and lead. There were no reported visual abnormalities. There was no trauma or falls that may have contributed to the high impedance. The explanted generator and lead were discarded per hospital policy.

 
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
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4496046
Report Number1644487-2015-03792
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/14/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/09/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2000
Device MODEL Number300-20
Device LOT Number14908C
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/14/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/21/1998
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-