BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 8915319 · Received August 21, 2019

    Report

    Report Number
    3004209178-2019-16056
    Event Type
    Malfunction
    Date Received
    August 21, 2019
    Date of Event
    August 14, 2019
    Report Date
    September 3, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00613994761057
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT AT THE TIME OF THE EVENT WAS CONFIRMED UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR ESSENTIAL TREMOR AND MOVEMENT DISORDERS. IT WAS REPORTED THAT WHILE AT AN IMPLANT REPLACEMENT SURGERY, PRE-OPERATIVE IMPEDANCE TEST SHOWED THE FOLLOWING OHMS: (0) 601 OHM, (1) 493, (2) 1414, (3) 461, (01) 59, (02) 1016, (03) LOW, (12) 1013, (13) LOW, (23) 68 OHMS. POST-OPERATIVE IMPEDANCE WAS OBSERVED AS: (0) 423 OHMS, (1) 334, (2) 355, (3) 335, (01) 77, (02) LOW, (03) 56, (12) 74, (13) LOW, (23) 56 OHMS. THE HEALTHCARE PROFESSIONAL CLOSED, AND THERE WERE NO PLANS MADE TO ADDRESS THE SHORT. THE PATIENT WAS STATED TO BE PROGRAMMED ON C 1- 2-." THE REPRESENTATIVE STATED THEY WERE COVERING A CASE OUTSIDE THEIR TERRITORY AND HAD NO FURTHER DETAILS TO PROVIDE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THE FOLLOWING: THE PATIENT HAD LOW IMPEDANCE BEFORE THE BATTERY CHANGE. THE LEAD WAS REINSERTED AND THE IMPEDANCE VALUES DID NOT IMPROVE. THE DOCTOR DECIDED TO LEAVE IT AS IS. THERE WAS NO FURTHER INFORMATION REGARDING THE RESOLUTION OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707605 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602 00613994761057

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR