BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1812484 · Received August 16, 2010

    Report

    Report Number
    3004209178-2010-06156
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 19, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POWER ON RESET CONDITION OCCURRED DURING A BREAST CANCER TREATMENT. IT WAS UNKNOWN WHETHER PATIENT HAD STIMULATION TURNED OFF DURING TREATMENT AND THE NUMBER OF TREATMENTS PATIENT UNDERWENT. PATIENT REPORTED RETURN OF SYMPTOMS ON LEFT SIDE OF BODY. INTERROGATION OF DEVICE FOUND SETTINGS AT 0V, 210PW/30HZ. IT WAS UNKNOWN WHETHER PATIENT WAS REPROGRAMMED AFTER POWER ON RESET. DURING IMPEDANCE TESTING OF THE LEFT DEVICE, THE PATIENT HAD A BAD PARESTHESIA REACTION ON LEFT SIDE OF BODY WITH" 500 UA AND 40 UA." PATIENT'S DEVICE WAS EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE MADE AVAILABLE AS FOLLOW UP AS IT 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 56 YR Required Intervention EXPLANTED:| LEAD: MODEL 3387, LOT# L80495| IMPLANTED: