• 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 07/17/2014
Event Type  Malfunction  
Event Description

It was reported that during generator replacement for battery depletion, high impedance was observed with the new generator attached to the existing lead. The patient was referred for lead replacement at a later time. An implant card was received indicating high impedance. The explanted generator for analysis. Analysis was completed on (b)(4) 2014. The device performed according to functional specifications. Therefore, the electrical performance of the generator, as measured in the pa lab, will be used to conclude that no abnormal performance or any other type of adverse condition was found with the generator. The patient underwent lead replacement. It was reported that device diagnostics with the new lead and existing generator was within normal limits (1275 ohms). The explanted lead has not been received for analysis to date.

 
Event Description

The explanted lead has been returned to the manufacturer where analysis is currently underway.

 
Manufacturer Narrative

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

 
Event Description

Analysis of the returned lead portion was completed. During the visual analysis, the coil appeared to be broken and identified the area as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Pitting was observed on the coil surface. The slice marks found on the outer silicone tubing and the cut ends that were made during the explanted process most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.

 
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 Key4074618
Report Number1644487-2014-02289
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/17/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/09/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2008
Device MODEL Number302-20
Device LOT Number1255
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/18/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/15/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/17/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-