BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1923222 · Received November 9, 2010

    Report

    Report Number
    3004209178-2010-09143
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 20, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    WITH STIMULATION TURNED ON, THE PT HAD A LOSS OF THERAPEUTIC EFFECT. THE PT'S DEVICE SYSTEM WAS NOT CONTROLLING THEIR PAIN, AND LATER HAD "STOPPED WORKING". THE PT'S PAIN WAS GETTING WORSE, AND A COMPANY REPRESENTATIVE WAS NOT READILY AVAILABLE IN (B)(6) TO REPROGRAM THE PT'S DEVICE. IT WAS FURTHER REPORTED THAT A SECOND DEVICE FROM AN ALTERNATIVE MANUFACTURER WAS IMPLANTED FOR CERVICAL PAIN; AND HAD STOPPED WORKING AFTER 8 MONTHS. THE PT WAS WORKING WITH THEIR PHYSICIAN IN AN EFFORT TO EXPLANT THEIR DEVICES. IT WAS NOTED THAT A PUMP WAS TO BE IMPLANTED ON (B)(6) 2010. THE PT'S OUTCOME WAS NOT REPORTED. ADDITIONAL INFORMATION IS BEING REQUESTED FROM THE HCP, AND WILL BE PROVIDED IN A F/U REPORT AS IT BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB023042V| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 39565-30, LOT# N133144001| EXPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA035556N| EXTENSION: MODEL 37081, LOT# NJB025080V