BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3092770 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07300
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3387S-40, LOT# V031485, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 7438, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS POSSIBLE BATTERY FAILURE AND THERE WAS UNKNOWN BATTERY DEPLETION. IT WAS NOTED THAT THE PATIENT WAS SCHEDULED FOR REPLACEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SUDDEN LOSS OF THERAPY. IT WAS NOTED THAT THE PATIENT PROGRAMMER SHOWED NO CHARGE AND THAT A NEW PATIENT PROGRAMMER ALSO SHOWED NO CHARGE. IT WAS NOTED THAT THE CLINICIAN PROGRAMMER COULD NOT COMMUNICATE WITH THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT THERE WAS NO HISTORICAL INS VOLTAGE MEASUREMENTS OR ACCESS TO THE THERAPY IMPEDANCE FOR BATTERY LONGEVITY CALCULATION. IT WAS REPORTED THAT THE PHYSICIAN SUSPECTED THAT THE ISSUE WAS 'PROBABLY HER BATTERY.' IT WAS REPORTED THAT THE PATIENT'S STIMULATION PARAMETERS HAD NOT BEEN CHANGED SINCE IMPLANTATION AND WERE SET AT AN AMPLITUDE OF 3.9 VOLTS, A PULSE WIDTH OF 60 MICROSECONDS, AND A RATE OF 185 HERTZ. IT WAS NOTED THAT THE LOSS OF THERAPEUTIC EFFECT OCCURRED AFTER THE PATIENT FELL THREE TIMES ON (B)(6) 2013. IT WAS NOTED THAT THE PATIENT DID NOT HAVE 'GREAT WALKING' BECAUSE SHE HAD MULTIPLE ORTHOPEDIC ISSUES. IT WAS NOTED THAT PRIOR TO THIS THE PATIENT WAS DOING FINE. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194823 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention