BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 4421554 · Received January 15, 2015

    Report

    Report Number
    3004209178-2015-00745
    Event Type
    Malfunction
    Date Received
    January 15, 2015
    Report Date
    December 23, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6) PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 37746, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3387S-40, LOT# V192123, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40, LOT# V192123, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT¿S DEEP BRAIN STIMULATION THERAPY WAS DEAD AND THEY HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT STATED THEIR IMPLANTABLE NEUROSTIMULATOR (INS) NEEDS TO BE REPLACED. THE INS ON THE RIGHT SIDE WAS TOTALLY DEAD AND THE LEFT INS WAS ¿FLUTTERING.¿ NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37478 SOLETRA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1