• 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 01/01/2013
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported that the patient was having the vns generator and lead explanted due to the generator being at end of service since 2014 and the patient being a non-responder when the generator was on. The explanted generator and lead were returned for product analysis. Product analysis on the generator found that it was at end of service and could not be communicated with. The battery's voltage was 0. 6v, the generator will no longer communicate after the battery reaches 1. 8v. Product analysis on the lead identified fractures of the quadfilar coils and abraded openings of the outer and inner tubings. It was also noted that the quadfilar coil had signs of pitting which appeared to be the result of stimulation being provided after the fracture had occurred. Review of the internal programming history database contained data up until (b)(6) 2012 where diagnostic results were within normal limits. Therefore it is known that the lead fracture occurred after (b)(6) 2012. Due to the pitting that was observed it is likely that the fracture occurred prior to the generator's end of service condition.

 
Manufacturer Narrative

Corrected data: describe event or problem; this information was inadvertently left off on mfg. Report #0.

 
Event Description

Product analysis found fluid leaks in the lead.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEAD MODEL 302
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 Key5791147
Report Number1644487-2016-01578
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup
Report Date 06/18/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/13/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2010
Device MODEL Number302-20
Device LOT Number200471
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/02/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/03/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/28/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-