BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2547680 · Received April 25, 2012

    Report

    Report Number
    3004209178-2012-02651
    Event Type
    Malfunction
    Date Received
    April 25, 2012
    Report Date
    April 2, 2012
    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
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXTENSION: MODEL 7482A40, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: NA. LEAD: MODEL 3889S-40, LOT #V279715, IMPLANTED: 2009 (B)(6), EXPLANTED: NA. CONCOMITANT INS SYSTEM: NEUROSTIMULATOR: MODEL 7426, SERIAL #(B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: NA. EXTENSION: MODEL 7482A40, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: NA. LEAD: MODEL 3889S-40, LOT #V230720, IMPLANTED: 2009 (B)(6), EXPLANTED: NA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT WHICH BEGAN ABOUT 6 MONTHS AGO. IT WAS NOTED THAT THERE WAS NO ACCIDENT OR INCIDENT RELATED TO THIS EVENT. IMPEDANCE MEASUREMENTS SHOWED >2000 OHMS ON ALL UNIPOLAR ELECTRODE PAIRS. THE COMPANY REPRESENTATIVE ATTEMPTED TO REPROGRAM THE PATIENT AT HIGHER AMPLITUDES BUT THE PATIENT DID NOT RECEIVE ANY BENEFIT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. SEE ALSO MANUFACTURER'S REPORT # 3004209178-2012-02649.

    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