BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5594653 · Received April 21, 2016

    Report

    Report Number
    3004209178-2016-07922
    Event Type
    Injury
    Date Received
    April 21, 2016
    Date of Event
    October 1, 2015
    Report Date
    April 21, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3387S-40, LOT# V021705, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HIS LEAD WAS PROTRUDING AND EXPOSED FROM HIS SCALP AND WAS CONTAMINATED, SO IT NEEDED TO BE REPLACED. THEY TRIED TO SALVAGE THE IMPLANTABLE NEUROSTIMULATOR (INS), BUT IT BECAME INFECTED AND HAD TO REPLACE THAT AS WELL. THE LEAD ISSUE OCCURRED IN (B)(6) 2015 AND THE INS BECAME INFECTED IN (B)(6) 2015. THE PATIENT'S INDICATIONS FOR USE WERE ESSENTIAL TREMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250573 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention