BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2870855 · Received December 12, 2012

    Report

    Report Number
    3004209178-2012-11775
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Report Date
    November 17, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3389S-40 LOT# V095377, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S DEVICE WAS REPLACED DUE TO NORMAL BATTERY DEPLETION. THE LOW IMPEDANCE ISSUE WAS FROM A SHORT IN THE LEAD THAT WAS A KNOWN ISSUE AND IT WAS PROGRAMMED AROUND WITH "GOOD EFFECT". NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT ELECTRODE HAD A SHORT CIRCUIT. IMPEDANCE MEASUREMENTS WERE BELOW 50 OHMS ON 0/1, 0/2 AND 1/4. IT WAS NOTED THAT THE PATIENT'S THERAPEUTIC SETTINGS WERE NOT AFFECTED BY THE SHORT CIRCUITS. THE PATIENT'S NEUROSTIMULATOR WAS REPLACED ON (B)(6). FOR EVENTS OCCURRING AFTER THE REPLACEMENT, AND PATIENT OUTCOME SEE MFR. REP. # 3004209178-2012-11306.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1