• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • 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 11/13/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient device was tested during an office visit on (b)(6) 2014 and system diagnostic results revealed high impedance (impedance value >= 10,000 ohms). The patient¿s device was subsequently disabled. X-rays dated 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. 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. Based on the images provided, the cause of the high lead impedance remains unknown. Follow-up revealed that the patient underwent surgery on (b)(6) 2014. Pre-operative system diagnostics showed high impedance (impedance value >= 10,000 ohms). A replacement generator was connected to the existing lead tested with the existing lead and system diagnostic results showed lead impedance within normal limits (impedance value ¿ 3708 ohms and 4111 ohms). The surgeon believed that incomplete lead pin insertion was the cause of the high impedance condition so the lead was not replaced during the procedure. When the patient was closed and dressed, the surgeon tested the device multiple times and high impedance was observed (impedance value >= 10,000 ohms). It was noted that the patient¿s body position remained mostly unchanged during the procedure. The patient was referred for additional surgery, but surgery has not occurred to date.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description

Analysis of the returned lead was completed which confirmed discontinuity of the negative quadfilar coil in the electrode region. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the break location. However, due to pitting, mechanical distortion (smoothed surfaces) and surface contamination the fracture mechanism cannot be determined. 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 end of the returned lead portions. Based on the appearance of the returned lead portions, it is believed that the identified punctures, kinks, superficial cuts/scratches, and tubing cut openings 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 portions.

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 lead replacement surgery on (b)(6) 2014. The explanted lead has 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)
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key4326952
Report Number1644487-2014-03301
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Type of Report Initial,Followup,Followup
Report Date 11/13/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/12/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2014
Device MODEL Number302-20
Device LOT Number2658
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 Received01/22/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/06/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial