BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3170957 · Received June 14, 2013

    Report

    Report Number
    3004209178-2013-10410
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    December 20, 2012
    Report Date
    May 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3387-40, LOT# J0235499V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 3387-40, LOT# J0235499V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 748266, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS NOTED THAT BOTH DEVICES WERE ON THE LEFT SIDE. ONE DEVICE WAS IN THE CHEST AND ONE DEVICE WAS IN THE ABDOMEN. IT WAS UNCLEAR WHICH DEVICE HAD HIGH IMPEDANCE AND REVISED. IT WAS ALSO NOTED THAT THE ABDOMEN EXTENSION WAS BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPEDANCE READING WAS >40,000 OHMS. REVISION PROCEDURE WAS SCHEDULED. IT WAS LATER REPORTED THAT SURGERY WAS PERFORMED ON THE PATIENT AND IT WAS DETERMINED THAT THE EXTENSION WAS NOT ALIGNED PROPERLY IN THE CONNECTOR BLOCK OF THE BATTERY. THIS WAS CORRECTED AND AN IMPEDANCE CHECK SHOWED IMPEDANCES WITHIN NORMAL RANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270412 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention