BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2061916 · Received April 5, 2011

    Report

    Report Number
    3004209178-2011-02598
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 8, 2011
    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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD A FALL THE PREVIOUS WEEKEND AND SUBSEQUENTLY EXPERIENCED A LOSS OF STIMULATION AND THERAPEUTIC EFFECT. THE PATIENT PROGRAMMER SHOWED THE INS WAS DEAD. INITIALLY AFTER THE FALL, SHE FELT STIMULATION BUT THEN SHE ONLY FELT STRANGE SENSATIONS DOWN HER LEGS TO HER TOES WHEN PUSHING ON THE INS. SHE ALSO EXPERIENCED A SHOCKING/JOLTING SENSATION. THE INS ALSO APPEARED TO BE SITTING AT A DIFFERENT ANGLE AFTER THE FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR ACCESSORY: MODEL 37752, LOT# NKA032306N| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD057795N| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC004964N| LEAD: MODEL 3998, LOT# V005789| LOT # NJH717870H| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37711| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3998, LOT# V005789| EXTENSION: MODEL 37083, LOT# NKC014925N| EXPLANTED:| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD062819N| EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC014924N| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC004801N