BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2690709 · Received August 10, 2012

    Report

    Report Number
    3004209178-2012-06751
    Event Type
    Injury
    Date Received
    August 10, 2012
    Report Date
    July 13, 2012
    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 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER; PRODUCT ID 37085-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT # V221331, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT # V126057, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A NEW INTERNAL NEUROSTIMULATOR (INS) IMPLANTED MUCH SOONER THAN EXPECTED. IT WAS NOTED THAT THE PATIENT ''WENT ALL WEEKEND WITH SYMPTOMS AND WAS SHAKING'' BEFORE THE IMPLANTATION. IT WAS FURTHER NOTED THAT IT TOOK 24 HOURS AFTER THE IMPLANTATION OF THE NEW DEVICE TO REDUCE HER SHAKING. THE PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention