BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3984247 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-14027
    Event Type
    Injury
    Date Received
    August 6, 2014
    Report Date
    July 31, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: 2010 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), EXPLANTED: 2010 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40, LOT# V052172, IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), EXPLANTED: 2010 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40, LOT# V052172, IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED ON (B)(6) 2010 THAT THE PATIENT¿S SHAKING HAD RETURNED FOR THE PAST SIX MONTHS. THE PATIENT STATED THAT SHE WAS SHAKING JUST AS BAD WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) ON AS SHE DID WITH IT OFF. REPROGRAMMING TYPICALLY HELPED FOR TWO TO THREE WEEKS, BUT THE PATIENT¿S MOST RECENT REPROGRAMMING DID NOT HELP FOR MORE THAN 24 HOURS. ALMOST FOUR YEARS LATER, THE PATIENT REPORTED THAT HER INS¿S ¿QUIT WORKING,¿ SO THEY WERE REPLACED WITH ONLY ONE INS. THE EXTENSIONS WERE REPLACED AS WELL. BY ¿QUIT WORKING¿ THE INFORMATION REASONABLY SUGGESTS THE PATIENT WAS REFERRING TO THE RETURN OF SHAKING. REFER TO MANUFACTURING REPORT #3004209178-2009-03604 AS THE PATIENT HAD THE LEFT SIDE IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED PRIOR TO THE LOSS OF EFFECT BECAUSE OF A FALL AND SHOCKING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY, AND IT WAS NOTED THAT THE PATIENT NEEDED A NEW MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462081 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention