BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3172585 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10433
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 29, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V054604, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 7438, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED ON (B)(6) 2013. IT WAS STATED THE BATTERY ¿HAD REACHED THE END OF ITS NORMAL LIFE.¿ IT WAS NOTED THE PATIENT¿S SECURITY WAND EVENT WAS NEVER REPORTED TO THEIR DOCTOR¿S OFFICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON TWO DIFFERENT OCCASIONS THE PATIENT WAS ¿HIT WITH A SECURITY WAND.¿ IT WAS THOUGHT THAT THE WANDS COULD HAVE WEAKENED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR BATTERY. ADDITIONAL INFORMATION 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
    273221 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR