BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3761314 · Received April 21, 2014

    Report

    Report Number
    3004209178-2014-07560
    Event Type
    Injury
    Date Received
    April 21, 2014
    Report Date
    April 1, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3389S-40, LOT# V382026, IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3389S-40, LOT# V382026, IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3389S-40, LOT# V382026, IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE LEADS WAS GOING TO BE REPLACED. PATIENT WAS GOING TO HAVE AN MRI ON (B)(6) 2014 WHICH WOULD DET ERMINE LEAD REPLACEMENT. IT WAS NOTED THAT THE LEADS WERE FINE AND THEY WORKED GREAT BUT BECAUSE, THE PATIENT WAS UNABLE TO HAVE AN MRI DUE TO A PACEMAKER A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS USED AND THE HEALTHCARE PROFESSIONAL HAD NOT HIT THE EXACT SPOT WHEN THE PATIENT WAS IMPLANTED IN ON (B)(6) 2010. PATIENT WAS NOW ABLE TO HAVE AN MRI. PATIENT INQUIRED ABOUT HOW LONG THE BATTERY WOULD LAST. ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS AWAITING SURGERY DUE WITH ONLY CT. THERE WAS INDIRECT TINGLING. THERE WERE NO ABNORMAL IMPEDANCE MEASUREMENTS. THERE WAS A LEAD REVISION. IT WAS NOTED THAT NOW THAT THE PATIENT HAD AN MRI COMPATIBLE PACEMAKER THEY COULD LIKELY PRE-FORM HIS LEAD LOCATION. THE LEADS EQUALLY COVERED BUT HE HAD A RELATIVELY POOR THRESHOLD. THE PATIENT HAD REQUIRED HOSPITALIZATION DUE TO THE EVENT AND THERE WAS NO PATIENT INJURY. IT WAS NOTED THAT THE REVISION WAS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240332 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization