BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 5112195 · Received September 29, 2015

    Report

    Report Number
    3004209178-2015-18959
    Event Type
    Malfunction
    Date Received
    September 29, 2015
    Date of Event
    September 23, 2014
    Report Date
    September 24, 2014
    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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7426, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 7438, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3389S-40, LOT # V167785, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT # V130326, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 7426, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF EFFICACY WHICH WAS UNRELATED TO THE STIMULATION THERAPY. THEY HAD A BURNING SENSATION AT THE IMPLANTABLE NEUROSTIMULATOR (INS) LOCATION AND THERE WAS BURNING IN THE INS. THE BURNING HAD BEGUN THE NIGHT PRIOR TO REPORT AND THEY HAD ANOTHER EPISODE ON THE DAY OF REPORT. IT WAS NOTED THE PATIENT FELL CONTINUOUSLY AND THEY HAD DAMAGED NERVES IN THEIR FOOT. THEIR WORST FALL WAS 3 MONTHS PRIOR TO REPORT AND THEY HAD FALLEN MANY TIMES SINCE THEN. THE PATIENT HAD LOST THE ABILITY TO WALK AND THEY WOUND UP IN A WHEELCHAIR AND THEY WERE SUFFERING FROM THE INJURY. THE PATIENT WAS BED BOUND AND THEY COULD NOT GET TO THE HEALTH CARE PROFESSIONAL (HCP). THE NIGHT PRIOR THE PATIENT HAD TROUBLE WITH ¿BOTH BOXES STINGING HIM.¿ IT WAS LIKE ¿BURNING HOT ON BOTH SIDES.¿ WHEN THEY FELT THE STIMULATORS THEY DID NOT FEEL HOT. THE LEFT ONE DID NOT LIGHT UP AT ALL JUST THE 9V LIGHT WHICH THEY ASSUMED THE BATTERY WAS DEAD. THE RIGHT SIDE DID LIGHT UP AND THEY TURNED OFF THE STIMULATION. IT WAS CLARIFIED THAT THE PATIENT HAD BURNING ON THE LEFT SIDE ONLY AND THE RIGHT SIDE WAS OFF. IT WAS A ¿CIGARETTE FEELING¿ OVER THE INS LOCATION. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD FAILED TO FOLLOW-UP WITH THEIR HCP AND THEY WERE LAST SEEN IN (B)(6) 2013. IT WAS UNKNOWN IF IT WAS DEVICE RELATED AND IF REPROGRAMMING WAS NEEDED. THE PATIENT OUTCOME WAS UNKNOWN. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. THE PATIENT WAS IMPLANTED FOR PARKINSONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641261 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR