BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6094240 · Received November 10, 2016

    Report

    Report Number
    3004209178-2016-23697
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    October 8, 2016
    Report Date
    December 22, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387-40, LOT# V001519, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER (HCP). IT WAS CONFIRMED THAT THE LEAD'S IMPLANT DATE WAS ON (B)(6) 2016. IT IS UNKNOWN IF PRIOR TO IMPLANTATION THE LEAD WAS IN THE HOSPITAL/CLINIC STOCK ON CONSIGNMENT OR IF IT WAS GIVEN TO HCP FROM A MANUFACTURER REPRESENTATIVE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR E SSENTIAL TREMOR AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE LEAD WAS IMPLANTED PASTED ITS USE BY DATE (UBD) AS THE DEVICE WAS IMPLANTED ON (B)(6) 2010 WHILE THE UBD WAS (B)(6) 2009. THERE WAS NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE HCP REPORTED THAT THE LEAD WAS IMPLANTED ON (B)(6) 201, AND THAT IT IS UNKNOWN IF PRIOR TO IMPLANT IF THE LEAD WAS IN THE HOSPITAL STOCK OR CONSIGNMENT OR IF GIVEN TO BY A MANUFACTURER REPRESENTATIVE (REP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745719 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR