BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1941190 · Received December 22, 2010

    Report

    Report Number
    3004209178-2010-10696
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    January 1, 2010
    Report Date
    December 10, 2010
    Manufacturer
    MEDTRONIC 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). ANALYSIS OF THE RECHARGER REVEALED PINS 4 AND 5 OF THE ANTENNA JACK WERE ELECTRICALLY OPEN.

    Description of Event or Problem · 1

    IF FELT LIKE STIMULATION BRIEFLY TURNED ON AND OFF. WHEN IT CAME BACK ON, IT FELT 'HARDER'. THIS OCCURRED 6-8 TIMES SINCE THE DEVICE WAS IMPLANTED IN (B)(6) 2010. IT DID NOT SEEM TO BE ASSOCIATED WITH POSITION OR ENVIRONMENT, BUT MAINLY OCCURRED WHEN HE WAS SITTING. THE PT ALSO EXPERIENCED PAIN WHERE THE LEAD CONNECTED TO THE IMPLANTABLE NEUROSTIMULATOR FOR SEVERAL MONTHS AFTER IMPLANT. THE PT REPORTED NO FALLS OR TRAUMA. THE PT PROGRAMMER ONLY WORKED WHEN USED WITH THE ANTENNA. THE PT PROGRAMMER WAS REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR PROGRAMMER: MODEL 37743, LOT # NKE141512N| PROGRAMMER: MODEL 37743, LOT # NKE142112N| LEAD: MODEL 39565-65, LOT # V398369012| IMPLANTED:| RECHARGER: 37752, LOT # NKA136042N| EXPLANTED:| IMPLANTED:| EXPLANTED: