BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2102380 · Received May 20, 2011

    Report

    Report Number
    3004209178-2011-03713
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 26, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE SYSTEM WAS NOT WORKING. PT HAD AN MRI WHILE SHE WAS OUT DURING HER HOSPITAL STAY IN (B)(6). PT REPORTED NO STIMULATION SENSATION AND BEING UNABLE TO ADJUST THE STIMULATION. THE PT'S STATUS WAS UNK. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 59 YR IMPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT# V207868029| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB053523V| STIM ACCESSORY: MODEL 3550-29, LOT# N188729| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE123468N| EXPLANTED:| EXPLANTED: