BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1915530 · Received November 5, 2010

    Report

    Report Number
    3004209178-2010-08958
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    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
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HEALTH CARE PROFESSIONAL THAT THERE WAS A LOSS OF EFFICACY THAT WAS "UNRELATED TO STIMULATION THERAPY." THE PT, WHO HAD BEEN LIVING IN A NURSING HOME FOR THE PAST TWO YEARS, "FELT LIKE HE DID NOT HAVE THE STIMULATOR IMPLANTED THE PAST SATURDAY." THE HCP INDICATED THAT NO PROCEDURE WAS DONE, AND WAS UNAWARE OF ANY NEW EQUIPMENT NEAR THE PT. IMPEDANCE READINGS WERE NORMAL. THE PT WAS GETTING "GREAT SPEECH AND CONTROL OF TREMOR." A POWER ON RESET CONDITION WAS ALSO REPORTED. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT NEAR END OF LIFE. A LONGEVITY CALCULATION WAS PERFORMED TO ESTIMATE BATTERY LIFE: INS BATTERY SHOWED 3.72V. THE PARAMETERS AS OF (B)(6) 2010: 3.3V/90PW/185HZ. C+1-. THERAPY IMPEDANCE WAS 616 OHMS. FOUR DAYS LATER A POWER ON RESET CONDITION WAS AGAIN REPORTED. 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 SOLETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR EXPLANTED:| EXPLANTED:| LEAD: MODEL 3387, LOT#: L55338| EXPLANTED:| EXTENSION: MODEL 7495-25, LOT#: NAF009287N| MODEL 7426, LOT#: NFW160474H| IMPLANTED:| PROGRAMMER: MODEL 7438, LOT#: NHL008996P| IMPLANTED:| EXTENSION: MODEL 7495-25, LOT#: NAF010605N| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR:| IMPLANTED:| LEAD: MODEL 3387, LOT#: L64600| IMPLANTED: