BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 6742950 · Received July 25, 2017

    Report

    Report Number
    3004209178-2017-15554
    Event Type
    Injury
    Date Received
    July 25, 2017
    Date of Event
    May 21, 2012
    Report Date
    July 25, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    UDI-DI
    00613994934604
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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# V961943, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6)2016, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V961943, IMPLANTED: (B)(6)2012, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    A FRIEND/FAMILY MEMBER OF A PATIENT IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR ESSENTIAL TREMOR AND MOVEMENT DISORDERS REPORTED THEY WERE ORIGINALLY IMPLANTED IN 2012. IN (B)(6) 2016, THEY HAD A FULL DAY OF SURGERY TO REPLACE ALL THE WIRING AND INS BECAUSE THEIR HEALTHCARE PROFESSIONAL (HCP) SAID ¿THEY DIDN'T DO IT RIGHT.¿ THE LEADS AND WIRING WERE REPORTEDLY NOT PLACED PROPERLY IN THE PATIENT¿S BRAIN, SO THE HCP REDID IT TO PROVIDE BETTER COVERAGE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523067 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601 00613994934604

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention