BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1923167 · Received November 9, 2010

    Report

    Report Number
    3004209178-2010-09094
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 19, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PT'S DEVICE HAD TO BE CHARGED MORE OFTEN THEN EXPECTED. LOW/OUT OF RANGE IMPEDANCE MEASUREMENTS OF LESS THEN 50 OHMS OCCURRED ON ELECTRODES 6-7. A COMPANY REPRESENTATIVE REPROGRAMMED THE DEVICE TO EXCLUDE ELECTRODES 6-7, AND STIMULATION WAS INDICATED AS BEING OK. NO FURTHER INFO WAS REPORTED IN REGARDS TO ANY POSSIBLE ADDITIONAL INTERVENTION OR PT'S OUTCOME. ADDITIONAL INFO IS BEING REQUESTED, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR LEAD: MODEL 3778, LOT # V504557015| EXPLANTED:| ACCESSORY: MODEL 37752, LOT # NKA139265N| PROGRAMMER: MODEL 37743, LOT # NKE148800N| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED: