• 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 01/27/2015
Event Type  Malfunction  
Event Description

Analysis of the returned lead portion was completed on 10mar2015, which found a coil break at the end of the positive coil. Scanning electron microscopy showed flat surfaces on the coil strands and pitting on the connector ring.

 
Event Description

It was reported that during generator replacement surgery on (b)(6) 2015 due to battery depletion, the vns patient¿s replacement generator was tested with the existing lead and diagnostic results showed high impedance. It is believed that the implanting physician may have damaged the lead while opening the generator pocket; however, preoperative diagnostics were not performed due to failure to interrogate due to end of service so the high impedance condition may have been present prior to replacement surgery. The surgeon had issues removing the lead pin from the replacement generator so he explanted the entire system and implanted a brand new system. The open but unused generator and lead have not been returned to date. The depleted generator was returned to the manufacturer for analysis which confirmed the end of service condition due to normal battery depletion.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death or serious injury.

 
Event Description

The opened and unused generator and explanted lead have been returned to the manufacturer where analysis is currently underway. The issues removing the lead from the opened but unused generator was reported in manufacturer report # 1644487-2015-03985.

 
Manufacturer Narrative

Describe event or problem; corrected data: the previously submitted mdr inadvertently indicated the opened but unused generator and lead were returned to the manufacturer for analysis. The issues removing the lead from the opened but unused generator was reported in manufacturer report # 1644487-2015-03985. Device available for evaluation; corrected data: the previously submitted mdr inadvertently indicated that the device was not available for evaluation. Device evaluated by mfr; corrected data: the previously submitted mdr inadvertently indicated that the device was not returned to the manufacturer.

 
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 Key4532663
Report Number1644487-2015-03930
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 01/27/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/20/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2013
Device MODEL Number302-20
Device LOT Number201233
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/09/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/10/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/12/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-