• 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 01/16/2015
Event Type  Malfunction  
Event Description

It was reported that device diagnostics resulted in high impedance (dc dc code - 7). It was reported that the device would be programmed off and x-rays would be performed. The patient was referred for surgery. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.

 
Event Description

The explanted generator was returned to the manufacturer. Analysis of the generator found that it performed according to functional specifications. No anomalies were found with the pulse generator.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

It was reported that the patient underwent a full vns system replacement on 04/03/2015 due to lead discontinuity. System diagnostics on the new vns system returned impedance within normal limits. Further information was later received stating that the generator was replaced for a prophylactic replacement. The explanted lead had to be cut as it could not be completely dissected from the nerve. It was reported that a fracture had been observed on x-rays. X-rays were not sent to the manufacturer for review. The explanted devices have not been received to date.

 
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 770
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 Key4515984
Report Number1644487-2015-03828
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/16/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/13/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2016
Device MODEL Number302-20
Device LOT Number202003
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/04/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/24/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-