BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3241077 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12098
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 26, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37642 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708660 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 37603 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3389S-28 LOT# VA08MWU, IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3708660 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6),PRODUCT TYPE EXTENSION PRODUCT ID 3389S-28 LOT# VA08MWU, IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STAGE 2 IMPLANT ¿YESTERDAY¿ THE PATIENT WENT INTO A TACHYCARDIA EVENT. ASSISTANCE WAS CALLED IN AND THE PATIENT WAS PROVIDED ¿SOME DRUGS¿ WHICH STOPPED HER TACHYCARDIA EVENT. PRIOR TO THE EVENT THE RIGHT SIDE SYSTEM HAD BEEN COMPLETELY IMPLANTED. THE EVENT OCCURRED DURING DRAPING PRIOR TO THE LEFT SIDE SYSTEM BEING IMPLANTED. AFTER THE EVENT, THE LEFT SIDE SYSTEM WAS IMPLANTED WITH NO FURTHER ISSUES. THERE WAS NO KNOWN CAUSE AT THE TIME. FIVE DAYS LATER, IT WAS REPORTED THAT IMPEDANCE TESTING WAS PERFORMED IN THE OPERATING ROOM DURING THE CASE AND ALL WERE WITHIN NORMAL LIMITS. NO MALFUNCTIONS WERE SEEN OR THE CAUSE OF THE ISSUE DETERMINED. THE PATIENT WAS DOING FINE AND THE DEVICE WAS TO REMAIN OFF FOR TWO WEEKS WHICH WAS NORMAL PROCEDURE FOR THE HOSPITAL AND HEALTH CARE PROVIDERS (HCP). REFER TO MANUFACTURING REPORT #3004209178-2013-12097 AS THE PATIENT HAD TWO SYSTEMS IMPLANTED ON THE DAY OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341338 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention