• 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 11/12/2013
Event Type  Malfunction  
Event Description

It was reported that the patient underwent lead replacement due to high impedance (10,000 ohms). It was reported that x-rays did not show a lead fracture or any abnormalities. It was reported that the patient experienced a good clinical response with vns. Pre-operative diagnostics identified that the generator had not yet been programmed off. The device was programmed off prior to the patient going to the operating room. It was reported that the surgeon decided to implant the new lead on the patient's right vagus nerve. The lead was cut at the connector pin and the explanted portion was returned to manufacturer for analysis. Analysis is underway, but has not been completed to date.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records of the lead 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.

 
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 Key3547746
Report Number1644487-2014-00014
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/06/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/02/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2013
Device MODEL Number302-20
Device LOT Number2456
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/17/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/06/2013
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/17/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-