BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1915528 · Received November 5, 2010

    Report

    Report Number
    3004209178-2010-08953
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 15, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AFTER "RIDING FOR EIGHT HOURS IN A CAR." IT WAS STATED THAT, WHEN THE PT TRIED TO INCREASE THE STIMULATION ON THEIR DEVICE, THE PT PROGRAMMER SHOWED AN "OUT OF REGULATION" MESSAGE. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    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 70 YR IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT#: NKE152283N| LEAD: MODEL 3778, LOT#: V530605018