BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6158104 · Received December 9, 2016

    Report

    Report Number
    3004209178-2016-25515
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    June 14, 2016
    Report Date
    December 9, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00613994761071
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR.

    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 THEY NEVER GOT TO DO FINAL ADJUSTMENTS ON HIS DEVICE AND THOUGHT THERE WAS A SHORT IN IT. HE NOTED THAT WHEN HE LIED ON A COUCH IN A CERTAIN POSITION, THE DEVICE SENT STIMULATION DOWN HIS ARMS. HE HAD TRIED DECREASING STIMULATION, BUT THAT DID NOT RESOLVE THE ISSUE. THE ISSUE HAD OCCURRED SINCE THE SECOND IMPLANT WAS PLACED. THE PATIENT MENTIONED HE FELL PROBABLY THIRTY DAYS AGO, IN (B)(6) 2016, AND AGAIN TWO WEEKS AGO. NO TROUBLESHOOTING HAD BEEN PERFORMED AND HE WAS SENT HEALTHCARE PROVIDER (HCP) LISTINGS TO FIND A NEW HCP. THE PATIENT¿S INDICATION(S) FOR USE WERE ESSENTIAL TREMOR AND MOVEMENT DISORDERS. REFER TO MANUFACTURING REPORT #3004209178-2016-25513 AS THE PATIENT HAD TWO INSS AND IT WAS NOT CLEAR WHICH ONE WAS INVOLVED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812892 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603 00613994761071

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR