BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5507774 · Received March 17, 2016

    Report

    Report Number
    3004209178-2016-04810
    Event Type
    Injury
    Date Received
    March 17, 2016
    Report Date
    February 19, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: : PRODUCT ID: 3387S-40, LOT# V011138, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE REPORTED THAT THE PATIENT DID NOT RECEIVE FULL THERAPY BENEFIT AND REQUESTED A LEAD REVISION ON (B)(6) 2016. IT WAS INDICATED THAT SYSTEM WAS EXPLANTED INCLUDING IMPLANTABLE NEUROSTIMULATOR(INS), EXTENSION AND LEAD. THE LEAD WAS EXPLANTED ON (B)(6) 2016 AND ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. A WEEK LATER, REP PROVIDED THAT MRI WAS PERFORMED AND PATIENT RECEIVED A 50% IMPROVEMENT. THE INDICATIONS FOR USE FOR THIS PATIENT WERE DYSTONIA AND MOVEMENT DISORDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164903 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention