BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3111041 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07608
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 28, 2013
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA # UPDATED/CORRECTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7438, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3389S-40, LOT # V037067, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD PRODUCT; ID 7482A40, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 7438, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT SINCE ABOUT A MONTH PRIOR TO THE REPORT THE PATIENT'S DYSKINESIA RETURNED AROUND 2:00 TO 2:30 P.M. EACH DAY AND THEN WOULD SUBSIDED. IT WAS FURTHER NOTED THAT THIS HAS GOTTEN WORSE IN THE TIME MORE RECENT TO THE REPORT AND HAPPENED DURING THE PHONE CALL TO REPORT THE ISSUE. IT WAS FURTHER REPORTED THAT THE PATIENT PROGRAMMER WAS NOT FUNCTIONING PROPERLY ON THE DAY PRIOR TO THE REPORT ((B)(6) 2013) WHEN CHECKING THE PATIENT'S DEVICE. A NEW BATTERY WAS PURCHASED AND THEN IT REPORTEDLY WOULD INTERMITTENTLY GO FROM NO STATUS LIGHTS, TO ALL STATUS LIGHTS, TO ONLY THE PATIENT PROGRAMMER BATTERY LIGHT, TO 2 TOP LIGHTS, AND THEN ONLY THE BOTTOM PATIENT PROGRAMMER BATTERY LIGHT. THE ORDER AND TIMELINE FOR THE LIGHT CHANGES WAS UNCLEAR. IT WAS ALSO NOTED THAT THE PATENTING WAS SEEING THE BATTERY ICON WITH A QUESTION MARK. T HE IMPLANTED DEVICE WAS REPORTEDLY MORE THAN 6 YEARS OLD. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE CAUSE OF THE EVENT WAS A LOW BATTERY LIGHT ON THE ¿REMOTE¿ AND THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) DEPLETED. IT WAS REPORTED THE BATTERY DEPLETION WAS NORMAL AND THE PATIENT HAD THEIR INS REPLACED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211749 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1