• 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 11/03/2014
Event Type  Malfunction  
Manufacturer Narrative

Manufacturer device history records were reviewed. Review of the lead device history records confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

During scheduled generator replacement on (b)(6) 2014, the surgeon observed the lead insulation was broken about three inches from the lead pin in the chest area after the generator was removed. The break in insulation was reported to be about 1/8 inch long. It was reported that portion of the lead had been coiled, and placed underneath the generator when originally implanted. The impedance was measured when the new generator was connected, and the impedance value was within normal limits at 1887ohms. The case was completed without replacing the lead.

 
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 Key4228552
Report Number1644487-2014-02942
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 11/03/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/05/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2002
Device MODEL Number300-20
Device LOT Number35576C
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/03/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/22/2000
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-