BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 2141192 · Received June 22, 2011

    Report

    Report Number
    1644487-2011-01389
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    February 24, 2006
    Report Date
    May 23, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF LABELING PERFORMED. DEVICE MFG RECORDS WERE REVIEWED. REVIEW OF MFG RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY A PHYSICIAN'S OFFICE THAT THE PT HAD THEIR GENERATOR MOVED AS "SHE HAD PICKED AT IT DOWN TO THE DEVICE". THE DEVICE HAD NOT BEEN REPLACED AT THIS TIME, AND THE LEADS WERE LEFT INTACT. LATER INFO INDICATED THAT THE PT WOULD NOT LIKE THE VNS IMPLANT ANY LONGER; FURTHERMORE, THE SITE HAD REPORTEDLY BECOMES INFECTED PRIOR TO ITS EXPLANT. F/U WITH THE PHYSICIAN REVEALED THAT THE PT HAD ALWAYS BEEN A "PICKER" AND SHE HAD EXPOSED THE DEVICE BY HER PICKING. HOWEVER, THE PHYSICIAN STATED, THE EXTRUSION WAS NOT RELATED TO VNS AT THIS TIME. A REVIEW OF THE MFR'S DESIGN HISTORY RECORDS INDICATED THAT BOTH THE LEADS AND THE GENERATOR WERE PROPERLY STERILIZED PRIOR TO SHIPPING. THE GENERATOR WAS RETURNED TO THE MFR FOR ANALYSIS AND WAS FOUND TO HAVE NO SHARP EDGES OR OTHER SURFACE ANOMALIES. THE PULSE GENERATOR WAS FOUND TO BE OPERATING WITHIN DESIGNED LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R LYJ CYBERONICS, INC. 102R 9728

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR