BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3396528 · Received October 9, 2013

    Report

    Report Number
    3004209178-2013-17717
    Event Type
    Injury
    Date Received
    October 9, 2013
    Report Date
    September 19, 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
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3 7085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V902308, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V911924, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (B)(4) FOUND NO SIGNIFICANT ANOMALY. IT WAS NOTED THAT THE BATTERY HAD REACHED NORMAL END OF LIFE. TELEMETRY AND OUTPUT WERE OK. IT WAS NOTED THAT THE BATTERY WAS AT END OF SERVICE AND WOULD NOT CLEAR.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS DEPLETED AND REPLACED. IT WAS NOTED THE PATIENT¿S RETURNED AS THE INS WAS DEPLETED. IT WAS NOTED THE PATIENT¿S HEALTHCARE PROFESSIONAL (HCP) REQUESTED THE INS BE ANALYZED AS THE SERVICE LIFE WAS 16 MONTHS AND THEIR EXPECTATION WAS THAT THE INS WOULD HAVE LASTED LONGER. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S HCP THINKS THE INS RAN OUT TOO SOON. ADDITIONAL INFORMATION RECEIVED REPORTED THE INS BATTERY DEPLETION WAS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512489 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention