BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3132094 · Received May 29, 2013

    Report

    Report Number
    1644487-2013-01609
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    March 15, 2013
    Report Date
    May 1, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH.

    Additional Manufacturer Narrative · 1

    BRAND NAME, CORRECTED DATA: INFORMATION RECEIVED INDICATES THAT THE EVENT SHOULD BE CAPTURED ON A DIFFERENT SUSPECT DEVICE. INFORMATION HAS BEEN CORRECTED ON THIS REPORT. TYPE OF DEVICE, CORRECTED DATA: INFORMATION RECEIVED INDICATES THAT THE EVENT SHOULD BE CAPTURED ON A DIFFERENT SUSPECT DEVICE.INFORMATION HAS BEEN CORRECTED ON THIS REPORT. MODEL #, SERIAL #, LOT #, EXPIRATION DATE, CORRECTED DATA: INFORMATION RECEIVED INDICATES THAT THE EVENT SHOULD BE CAPTURED ON A DIFFERENT SUSPECT DEVICE. INFORMATION HAS BEEN CORRECTED ON THIS REPORT. IF IMPLANTED, GIVE DATE, CORRECTED DATA: INFORMATION RECEIVED INDICATES THAT THE EVENT SHOULD BE CAPTURED ON A DIFFERENT SUSPECT DEVICE. INFORMATION HAS BEEN CORRECTED ON THIS REPORT. DEVICE MANUFACTURE DATE, CORRECTED DATA: INFORMATION RECEIVED INDICATES THAT THE EVENT SHOULD BE CAPTURED ON A DIFFERENT SUSPECT DEVICE. INFORMATION HAS BEEN CORRECTED ON THIS REPORT.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT HE PATIENT WAS HAVING AN INCREASE IN SEIZURES. WHEN DIAGNOSTICS WERE RUN IT WAS DETERMINED THAT THE PATIENT HAD HIGH IMPEDANCE (DCDC ¿ 7) WITH END OF SERVICE ¿ NO. SURGERY IS LIKELY BUT HAS NOT OCCURRED TO DATE. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    AS DESCRIBED IN FOLLOW-UP REPORT #1, ONCE THE GENERATOR WAS REPLACED, THE LEAD IMPEDANCE WAS WITHIN NORMAL LIMITS. THEREFORE, THE SUSPECT DEVICE SHOULD BE THE GENERATOR AND NOT THE LEAD.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD A GENERATOR REPLACEMENT. THE PRE-OPERATIVE DIAGNOSTICS SHOWED A DCDC OF 6. ONCE THE GENERATOR WAS REPLACED LEAD IMPEDANCE WAS WITHIN NORMAL LIMITS (3342 OHMS AND 3589 OHMS). THE GENERATOR WAS NOT AT END OF SERVICE.

    Description of Event or Problem · 1

    THE EXPLANTED DEVICE CANNOT BE RETURNED AS IT WAS DISCARDED BY THE NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236610 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 011040

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR