BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3367830 · Received September 25, 2013

    Report

    Report Number
    3004209178-2013-16917
    Event Type
    Injury
    Date Received
    September 25, 2013
    Report Date
    September 8, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389-40, LOT# V002947, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3389-40, LOT# V003007, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389-40, LOT# V003007, IMPLANTED: (B)(6) 2006, PRODUCT TYPE; LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DEVICE WAS TURNED OFF ON ONE SIDE. FIVE DAYS LATER, IT WAS REPORTED THAT THE PATIENT¿S DEVICE DISPLAYED AN END OF SERVICE/END OF LIFE (EOS/EOL) MESSAGE. THE REPORTER STATED THAT THE RIGHT SIDE IMPLANTABLE NEUROSTIMULATOR (INS) WAS OUT OF POWER. THE REPORTER STATED THAT THE PATIENT¿S CONTRALATERAL SIDE TREMOR HAD WORSENED THE WEEK PRIOR TO THIS REPORT. THE PATIENT HAD REPORTEDLY BEEN TOLD BY HIS MANAGING HEALTH CARE PROVIDER (HCP) THAT THE INS WOULD BE FINE UNTIL (B)(6). IT WAS NOTED THAT THE PATIENT WAS CURRENTLY HOSPITALIZED AND THE RIGHT SIDE INS, AND POSSIBLY THE LEFT SIDE INS, WOULD BE REPLACED. IT WAS LATER REPORTED THAT THE PATIENT WAS HOSPITALIZED AFTER THE INS HAD EXPIRED BECAUSE THE PATIENT HAD BEEN UNABLE TO TOLERATE THE RETURN OF MOTOR SYMPTOMS AFTER THE DEVICE TURNED OFF. IT WAS NOTED TO BE NORMAL BATTERY DEPLETION. THE PATIENT REPORTEDLY EXPERIENCED LESS THAN 50% THERAPY RELIEF DUE TO THE LEFT SIDE IMPLANT. IT WAS NOTED THAT THE PATIENT WAS SCHEDULED TO HAVE THE INS REPLACEMENT SURGERY ON (B)(6) 2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483843 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization