BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2102360 · Received May 20, 2011

    Report

    Report Number
    1644487-2011-01153
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS SCHEDULED FOR PROPHYLACTIC GENERATOR REPLACEMENT. DURING SURGERY, IT WAS NOTED THAT THERE WAS HIGH IMPEDENCE PRESENT WITH THE OLD GENERATOR. ONCE THE LEAD PIN WAS CLEANED AND A NEW GENERATOR WAS ATTACHED, DIAGNOSTICS WERE WITHIN NORMAL LIMITS. THE SURGEON NOTED THAT THE LEAD PIN AREA WAS "A LITTLE MESSY" WHICH MAY HAVE BEEN CAUSING THE HIGH IMPEDANCE. THE PT HAD COMPLAINED OF PAINFUL STIMULATION AT THE GENERATOR SITE, AND AFTER SURGERY, THE PT NO LONGER HAD PAIN WITH STIMULATION. EXPLANTED GENERATOR WAS RETURNED TO THE MFR, BUT ANALYSIS IS PENDING. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 012081

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR