• 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 02/03/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and multiple system diagnostic results revealed high impedance (impedance value >= 10,000 ohms). The patient¿s device was subsequently disabled. The patient¿s device was last tested on (b)(6) 2012 and system diagnostic results showed lead impedance within normal limits (impedance value ¿ 3225 ohms). X-rays were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin cannot be confirmed to be fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. A suspect area was identified distal to the positive electrode. Based on the images provided, the cause of the high lead impedance remains unknown. No known surgical interventions have occurred to date.

 
Event Description

It was reported that the patient underwent generator and lead replacement. Device diagnostics with he new vns system were within normal limits. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.

 
Event Description

Product analysis of the generator did not confirm the reported battery depletion and revealed that the device had not reached the ifi point and just under 25% of the battery had been consumed. Review of the internal device information shows an indication of increased impedance consistent with the initial report. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead confirmed discontinuity of positive coil at two locations in the electrode region of the returned lead portions. Scanning electron microscopy images of the positive coil breaks show that pitting or electro-etching conditions have occurred at the break locations. However, due to metal dissolution, mechanical distortion (smoothed surfaces) and/or surface contamination the fracture mechanism cannot be ascertained. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the cut ends of the returned lead. Based on the appearance of the returned lead portions, it is believed that identified punctures, kinks, tubing cuts, were most likely caused during the explant procedure. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead.

 
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 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 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 Key4210668
Report Number1644487-2014-02881
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 10/02/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/29/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2014
Device MODEL Number302-20
Device LOT Number2873
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/29/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/02/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/06/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-