BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3851548 · Received June 5, 2014

    Report

    Report Number
    9614453-2014-01060
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    April 1, 2014
    Report Date
    January 12, 2017
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLETED AS SERIOUS INJURY IN ERROR AND NO SERIOUS INJURY WAS REPORTED AS PART OF THE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE ADAPTOR ELECTRODE GOING TO THE STIMULATOR WAS DAMAGED DURING BATTERY REPLACEMENT. THE ADAPTOR WAS REPLACED. THERE WERE NO SIGNS OR SYMPTOMS REPORTED. ADDITIONAL INFORMATION REPORTED THE EVENT WAS PROCEDURE RELATED AND THE EVENT WAS NOTED AS RESOLVED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED DIAGNOSTIC METHODS INCLUDED A SURGICAL OBSERVATION ON (B)(6) 2014. ETIOLOGY WAS REPORTED AS SURGERY/ANESTHESIA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CLARIFIED THE CONTACT POINTS IN THE ADAPTOR WERE DAMAGED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REPLACEMENT OF THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS DUE TO NORMAL BATTERY DEPLETION. IT WAS NOTED THAT DURING EXPLANT THE INS CABLE WAS DAMAGED ON THE ADAPTER AND THEREFORE EXPLANTED AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329228 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC EUROPE SARL 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention