• 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 03/04/2015
Event Type  Malfunction  
Event Description

Analysis of the returned generator and lead was completed. The generator performed according to functional specifications. There were no anomalies found with the pulse generator. Analysis confirmed discontinuity of the positive quadfilar coil in the body region of the returned lead portions. An abraded opening of the positive inner tubing was observed near the break area. Scanning electron microscopy was performed on the connector end of the quadfilar coil break and identified the area as being mechanically damaged which prevented identification of the coil fracture type with pitting. Pitting was observed on the coil surface.

 
Manufacturer Narrative

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

 
Event Description

It was reported that the vns patient presented with neck pain. The patient¿s device was tested and diagnostic results showed high impedance. The patient¿s device was subsequently disabled. Since device disablement, the patient experienced a seizure while previously being seizure-free. Follow-up revealed that high impedance was observed on both normal mode and system diagnostic tests. The patient was referred for surgery but no known surgical interventions have occurred to date.

 
Manufacturer Narrative

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

 
Event Description

Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015 due to high impedance. The explanted devices have been returned to the manufacturer where analysis is currently underway.

 
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 Key4651958
Report Number1644487-2015-04352
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/10/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/02/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2014
Device MODEL Number302-20
Device LOT Number201541
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/17/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/11/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/09/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-