BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3050910 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05887
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    March 27, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3387S-40, LOT# V858673, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387S-40, LOT# V082506, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS GETTING THEIR IMPLANTABLE NEUROSTIMULATORS (INSS) 'PROPHYLACTICALLY' REPLACED. NO REPORTED ISSUES WITH THE LEFT IMPLANTABLE NEUROSTIMULATOR WERE REPORTED. THE PATIENT'S RIGHT SIDE DEVICE HAD HIGH IMPEDANCES, OVER 10,000 OHMS ON MULTIPLE COMBINATIONS. THE PATIENT'S DEVICE WAS PROGRAMMED TO CASE POSITIVE, 3 NEGATIVE WHICH WAS NOT REPORTED TO HAVE BEEN HIGH, AND THE PATIENT HAD REPORTEDLY BEEN 'OKAY' ON THAT PROGRAM. THE PHYSICIAN WAS GOING TO REPLACE THE DEVICE AND CHECK THE CONNECTIONS. AFTER REPLACEMENT ALL IMPEDANCES WERE NORMAL. EVERYTHING WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148618 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00027 YR Required Intervention