• 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 302-30
Event Date 02/06/2015
Event Type  Malfunction  
Event Description

It was reported that device diagnostics resulted in high impedance (dc dc code - 7). The patient was referred for surgery. The patient underwent generator and lead replacement due to high impedance and end of service. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.

 
Event Description

Analysis of the explanted devices was completed. The end of service condition of the generator was determined to be the result of normal battery depletion. There was no condition noted during the analysis that would suggest any anomaly with the device. Analysis of the returned lead portions confirmed discontinuity of positive quadfilar coil in the electrode region. Pitting and flat spots were observed on the coil surface on both sides of this lead discontinuity.

 
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.

 
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 Key4600254
Report Number1644487-2015-04141
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/16/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/13/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/01/2006
Device MODEL Number302-30
Device LOT Number6559
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/27/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/18/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/15/2002
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-