BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2102644 · Received May 23, 2011

    Report

    Report Number
    3004209178-2011-03725
    Event Type
    Malfunction
    Date Received
    May 23, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 26, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A LACK OF THERAPEUTIC EFFECT FOLLOWING A FALL. THERE WAS NO MOVEMENT IN HER ARMS AND LEGS AND HER TREMORS RETURNED. THE PT'S HEALTH CARE PROFESSIONAL REQUESTED THAT A MFR'S REP CHECK THE IMPEDANCES. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE. SEE ALSO MFR'S REPORT #3004209178-2011-03726.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR IMPLANTED:| LEAD: MODEL 3389S-40, LOT# V033439| LOT# NFW141908H| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU152075V| EXPLANTED:| LEAD: MODEL 3389S-40, LOT# V032588| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU150782V| IMPLANTED:| EXPLANTED: