BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1001707 · Received February 15, 2008

    Report

    Report Number
    3004209178-2008-00709
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Report Date
    January 18, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE REP REPORTED, THERE HAD BEEN LACK OF THERAPY BENEFIT AT F/U AT THE CLINIC, THE DEVICE WOULD NOT TURN ON AND COULD NOT BE INTERROGATED BY ANY PROGRAMMER FOLLOWING EXPOSURE TO AN AIRPORT SECURITY GATE. THE PRODUCT HAD BEEN TURNED OFF AT THE TIME OF THE EXPOSURE TO THE THEFT DETECTOR OR SECURITY GATE (THE DATE OF THE EVENT WAS NOT PROVIDED). THE PT PROVIDED THAT AFTER SHE BOARDED THE AIRPLANE, SHE COULD NOT TURN THE DEVICE ON; SHE STATED, THE PRODUCT WAS NOT A RECHARGEABLE DEVICE. HER CONDITION HAD BEEN FAIR. THE REP REVIEWED RECORDS, WHICH SHOWED THE INS WAS A RECHARGEABLE PULSE GENERATOR. THE PT HAD NOT BEEN RECHARGING THE DEVICE AND THE BATTERY STATUS WAS DEEMED TO BE OVER-DISCHARGED. THE REP COMMUNICATED WITH THE RECHARGER DEVICE AND A PHYSICIAN MODE RECHARGE WAS CONSIDERED BUT THE PT COULD NOT STAY TO COMPLETE THE PROCESS. ON 01/22/2008, THE REP INDICATED THAT THE PT HAD FOUND HER RECHARGER DEVICE; THERE WERE NO PLANS TO EXPLANT THE PRODUCT OR SYSTEM. ADD'L INFO HAS BEEN REQUESTED FROM THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| EXPLANTED| LEAD MODEL 3776| LEAD MODEL 3999| ACCESSORY MODEL 37752| PROGRAMMER MODEL 37742| EXTENSION MODEL 37082| EXPLANTED| EXPLANTED