BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3658065 · Received March 4, 2014

    Report

    Report Number
    3004209178-2014-03881
    Event Type
    Injury
    Date Received
    March 4, 2014
    Report Date
    February 11, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3389S-40, LOT# V011687, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3389S-40, LOT# V013037, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POCKET BECAME INFECTED AND THE DEVICE NEARLY ERODED THROUGH THE SKIN. IT WAS NOTED THAT THE HEALTH CARE PROFESSIONAL (HCP) FELT THIS WAS DUE TO THE SIZE AND SHAPE OF THE DEVICE WITH THE POCKET ADAPTOR THAT WAS REQUIRED. IT WAS NOTED THAT MOVING FORWARD THE HCP PLANNED TO REPLACE THE EXTENSIONS WHEN THEY REPLACED OLDER MODEL INSS WITH NEWER MODEL INSS TO AVOID USING THE POCKET ADAPTOR. IT WAS NOTED THAT AN EXPLANT WAS REQUIRED. IT WAS NOTED THAT A CULTURE WAS TAKEN AT THE DEVICE POCKET AND THE ORGANISM WAS UNKNOWN. IT WAS NOTED THAT ANTIBIOTIC TREATMENT WAS NECESSARY. IT WAS NOTED THAT THERE WAS PAIN AT THE DEVICE POCKET AND LEFT SIDE IMPLANT. IT WAS NOTED THAT THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT RECEIVE ANY DBS THERAPY AS THE INS AND EXTENSIONS WERE EXPLANTED. IT WAS NOTED THAT THEY WOULD BE REPLACED IN ABOUT 6 TO 8 WEEKS AFTER THE INFECTION CLEARED. IT WAS NOTED THAT THE DEVICES WERE DISPOSED OF BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128986 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention