BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 100

    MDR report key: 3182421 · Received June 21, 2013

    Report

    Report Number
    1644487-2013-01830
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    April 25, 2008
    Report Date
    May 23, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    CLINIC NOTES WERE RECEIVED THAT REPORTED THAT A PATIENT'S MAGNET WAS NOT WORKING WELL. THEIR DEVICE WAS INTERROGATED AND THEIR BATTERY WAS ALMOST COMPLETELY DRAINED. THE PATIENT WAS SENT FOR GENERATOR BATTERY REPLACEMENT ON (B)(6) 2008. HIGH IMPEDANCE WAS REPORTED TO HAVE BEEN ATTAINED IN THE OR ON THEIR SYSTEM TEST. RESULTS WERE 7 / LIMIT / HIGH, EOS = NO. NORMAL MODE DIAGNOSTICS SHOWED OUTPUT STATUS OKAY, LEAD IMPEDENCE OKAY, DCDC 1, NEAR EOS = YES. THEIR GENERATOR WAS REPLACED AND IT WAS NOT RETURNED FOR ANALYSIS. AT A LATER DATE INTERNAL PROGRAMMING HISTORY WAS REVIEWED THAT SHOWED THE PATIENT LIKELY HAD HIGH LEAD IMPEDANCE AROUND (B)(6) 2008 THAT APPEARED TO HAVE RESOLVED WITH REPLACEMENT OF THEIR GENERATOR. A PIN ISSUE IS POSSIBLE BUT NOT CONFIRMED AS THE CAUSE OF THEIR HIGH IMPEDANCE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283126 PULSE GEN MODEL 100 PULSE GEN MODEL 100 LYJ CYBERONICS INC 100C 22629C

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR