• 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
Device Problem Mechanical Problem
Event Date 11/23/2015
Event Type  Malfunction  
Event Description

The patient has been referred for a prophylactic generator replacement but before replacement surgery, the surgeon noticed inflammation in the neck area, near the lead placement. Before the patient was referred to surgery, they were being seen by a dermatologist who noticed a mass in the left neck, with no signs of infection. The dermatologist noted it to be a rapidly growing pyle on the left neck, suspect for pyogenic granuloma. A biopsy of specimen was taken and it came back as an "inflamed fibroepithelial polyp with hemosiderin deposition and edema. " at a follow-up appointment the dermatologist mentioned the mass to be an "8 mm flesh colored nodule on left neck - regrowth within three weeks" and the patient was injected with steroid at that time. At yet another follow up appointment, the mass bled with minimal trauma, therefore an excisional biopsy was taken and it returned as a pyogenic granuloma, with 1. 2cm at it's largest dimension. A later follow up revealed that healing occurred. The patient was referred to ent as the regrowth returned. A ct scan was done and it was reported "within skin overlying the surgical site, there is no enhancing contour with irregularity, also stable in size. This may represent a pyogenic granuloma as offered in the indication; also consider keloid/hypertrophic scar. There is no enhancement to suggest abscess". The surgeon mentioned that there was inflammation but no sign of infection where the lead is located. The epicenter of inflammation was located near the tie down. The surgeon was unable to determine whether the cause of inflammation was due to previous injections, incisions, the lead (which showed compromised insulation), or the tie downs. There was no obvious pus, but cultures were taken. Due to the inflammation the generator and a portion of the lead were explanted. The lead was cut and the surgeon left a small stump proximally in case re-implantation was needed. The removal site was washed out and the generator was removed in case no further implant is necessary. The patient was then put on antibiotics. A review of device history records for the generator and lead shows that no unresolved non-conformances were found. The explanted products have not been received to date.

Event Description

Additional information was received from the doctor indicating that the exact cause of compromised insulation is unknown. It was stated that there was fibrosis and granulation around the tissues, and the source of the granulation seemed to be the tie down. However it is notable that multiple steroid injections and biopsies were performed over the site. Therefore the doctor cannot be certain at which point, and during which surgeries, the lead insulation was compromised. No other relevant information has been received to date.

Event Description

System diagnostics were received for the device and indicate no lead fracture. The explanted products have not been received to date. No other relevant information has been received to date.

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
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 Key6868430
Report Number1644487-2017-04461
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 12/28/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/15/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2008
Device MODEL Number302-20
Device LOT Number1056
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/04/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/21/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 09/15/2017 Patient Sequence Number: 1