BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1812110 · Received August 17, 2010

    Report

    Report Number
    3004209178-2010-06184
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    January 1, 2010
    Report Date
    July 19, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE ON THE RIGHT SIDE WAS TURNING OFF WHILE THE PT WAS VACATIONING. THE PT VISITED A CLINIC AND ALL MEASURED IMPEDANCES WERE WITHIN THE NORMAL RANGE. ADDITIONAL 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 SOLETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7438, LOT # NHL005353P| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT # J0230919V| EXPLANTED:| LEAD: MODEL 3387, LOT # J0230919V| EXPLANTED:| EXTENSION: MODEL 7482, LOT # NGK019486N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387, LOT # N24972A| IMPLANTED:| EXPLANTED:| LOT # NFW113710H| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| EXTENSION: MODEL 7495-51, LOT # XR0094029N