BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2961650 · Received February 14, 2013

    Report

    Report Number
    3004209178-2013-02640
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 30, 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 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V951526, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT LEAD REVISION WAS PERFORMED. MORE THAN ONE WEEK LATER IT WAS REPORTED THAT THE INTERVENTION TAKEN WAS OPENING THE DEVICE POCKET AND RECONNECTING THE EXTENSION. IT WAS STATED IT WAS POSSIBLE THAT THE EXTENSION HAD NOT BEEN FULLY INSERTED ORIGINALLY. IMPEDANCES WERE NORMAL AND THERE WAS EXCELLENT TREMOR CONTROL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OR TWO OF THE FINE WIRES WITHIN THE EXTENSION THAT GO ACROSS THE GAP BETWEEN THE EXTENSION AND THE HUB THAT CONNECTS TO THE LEAD APPEARED TO BE SPLAYED OUT TO THE LEFT LIKE THEY MIGHT ACTUALLY BE FRACTURED THERE. ADDITIONAL INFORMATION RECEIVED REPORTED X-RAY SHOWED NO FRACTURES OR TWISTING; HOWEVER, IMPEDANCE TESTING SHOWED OPEN CIRCUITS FOR ALL CONTACTS. THE PATIENT WAS GOING TO HAVE SURGERY TO CHECK THE LEAD-EXTENSION CONNECTION. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64763 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention