BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 2043189 · Received March 25, 2011

    Report

    Report Number
    3004209178-2011-02294
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 18, 2011
    Report Date
    March 10, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (CRYOABLATION).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A CRYOABLATION PROCEDURE ON THE HEART. BEFORE THE PROCEDURE, THE STIMULATOR WAS FULLY CHARGED AND THEN TURNED OFF DURING THE PROCEDURE. AFTERWARDS, IT WAS IMPOSSIBLE TO GET "CONTACT" WITH THE STIMULATOR. A PHYSICIAN PROGRAMMER WAS FIRST USED TO UNSUCCESSFULLY INTERROGATE THE DEVICE. NEXT TWO DIFFERENT RECHARGERS WERE USED TO TRY TO COMMUNICATE WITH THE STIMULATOR, AND THIS WAS ALSO UNSUCCESSFUL. THE RECHARGER SCREEN SHOWED ERROR CODE 590 (=NO TELEMETRIE). A PHYSICIAN MODE RECHARGE WAS PERFORMED, AND AFTER ONE HOUR, THE RECHARGER SCREEN WENT BLANK/OFF. AN X-RAY WAS TAKEN TO SEE IF THE DEVICE WAS FLIPPED, AND THE RESULTS SHOWED THERE WAS NO FLIP. THE REPORTER CONCLUDED THE STIMULATOR WAS DAMAGED BY THE CRYOABLATION PROCEDURE THAT OCCURRED 2 WEEKS PRIOR. THE PATIENT WAS BEING TREATED WITH ANTICOAGULANTS BECAUSE OF CLOTTING DUE TO ATRIAL FIBRILLATION, AND DURING THE PROCEDURE, A CATHETER WAS INTRODUCED INTO THE PATIENT. THE REPORTER SUSPECTED UNIPOLAR ELECTROCAUTERY WAS USED WITH THE CATHETER INSERTION DUE TO THE RISK FOR BLEEDING FROM THE ANTICOAGULANTS. THE ELECTROCAUTERY COULD HAVE DAMAGED THE DEVICE. THE STIMULATOR WAS GOING TO BE REPLACED. THERE WAS NO PATIENT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGEABLE NEUROSTIMULATOR LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR