BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2881962 · Received December 20, 2012

    Report

    Report Number
    3004209178-2012-12089
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 19, 2012
    Report Date
    August 6, 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

    PRODUCT ID 37651, SERIAL# (B)(4), PRODUCT TYPE RECHARGER, PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 37085-60, SERIAL# (B)(4), PRODUCT TYPE EXTENSION, PRODUCT ID 3387S-40, LOT# V680690, PRODUCT TYPE LEAD, PRODUCT ID 3387S-40, LOT# V681753, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BILATERAL LEADS PLACED. THAT SAME NIGHT THE PATIENT SUFFERED FROM A SEIZURE AND CARDIAC ARREST. THE PATIENT HAD RECOVERED FULLY AND WAS DISCHARGED THAT WEEK. A LITTLE OVER A WEEK LATER THE STIMULATOR WAS PLACED AND EVERYTHING WENT "WITHOUT INCIDENT." THE PATIENT'S FIRST PROGRAMMING SESSION WAS SCHEDULED FOR (B)(6) 2012. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    FOLLOW UP REPORTED THE PATIENT WAS DOING "REMARKABLY WELL" AND WAS GETTING "GREAT" BENEFIT FROM THEIR DEVICE. THERE WAS NO MALFUNCTION SEEN OR A CAUSE OF ISSUE DETERMINED. IT WAS UNKNOWN IF ANY INTERVENTIONS WERE TAKEN OR PLANNED BUT AT THE TIME THE PATIENT WAS DOING "VERY WELL" AND THEIR SYSTEM WAS FUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00034 YR Hospitalization| R