• 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 10/01/2014
Event Type  Malfunction  
Event Description

On (b)(6) 2014 it was reported that the patient has high impedance on all diagnostics, so they turned the device off and ordered x-rays for the patient. The patient¿s last visit was in (b)(6) 2014 and the diagnostics were normal at that time. The patient¿s caretaker said she hadn¿t noticed the patient¿s voice go hoarse with stimulation in a while so thinks it may not have been working properly for a few months. They have not had any major falls or injuries. Although surgery is likely, it has not occurred to date. An x-ray assessment was performed on the x-ray images for the patient. The generator was visualized in the patient¿s left chest. The lead appeared to be intact at the lead pin. The filter feed thru wires appeared to be intact. The lead pin appeared to be fully inserted into the connector block. The electrodes appeared to be in alignment; however, the electrodes appear to be inverted on the patient¿s vagus nerve. Based on the x-rays received, the cause of the high impedance cannot be determined. However, a micro-fracture cannot be ruled out.

 
Manufacturer Narrative

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

 
Event Description

The patient had lead revision surgery on (b)(6) 2016. The generator was not replaced. System diagnostics were performed during the surgery, and high impedance was identified prior to the lead replacement. Once the lead was replaced, there was normal impedance. The explanted lead has not been received to date.

 
Event Description

The device history record of the lead was reviewed, and the device conformed to all specifications prior to release. The explanted lead was received on 05/09/2016. Analysis was approved on 06/02/2016. A break was identified in the positive coil. The positive coil showed that pitting of electro-etching conditions have occurred at the break location. One strand of the positive quadfilar coil showed minor appearance suggesting that a stress-induced fracture occurred in at least one strand. However, due to pitting and mechanical distortion (smoothed surfaces) the fracture mechanism of strands could not be ascertained. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead.

 
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
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 Key4268315
Report Number1644487-2014-03089
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,Distributor,COMPANY REPRESENTATI
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/27/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/21/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2016
Device MODEL Number302-20
Device LOT Number202196
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/09/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/09/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-