BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7743117 · Received August 2, 2018

    Report

    Report Number
    3004209178-2018-17256
    Event Type
    Malfunction
    Date Received
    August 2, 2018
    Report Date
    October 4, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00613994761057
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONTINUATION OF MEDICAL DEVICES: PRODUCT ID 3387-40 LOT# L74288, IMPLANTED: (B)(6) 2000 PRODUCT TYPE LEAD. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3387-40, SERIAL/LOT #: (B)(4), UBD: 02-DEC-2003, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE TREATMENT OF ESSENTIAL TREMOR AND MOVEMENT DISORDERS. IT WAS REPORTED AN IMPEDANCE CHECK WAS DONE ON (B)(6) 2018 TO SEE IF THE PATIENT COULD HAVE AN MRI FOR A POTENTIAL NEW LEAD PLACEMENT. THE IMPEDANCES SHOWED ELECTRODE 3 WAS OUT, THUS AN MRI WAS NOT DONE. C0 1236 OHMS C1 3014 C2 841 C3 40K 01 3671 02 1529 03 40K 12 3281 13 40K 23 40K OHMS GROUP IMPEDANCE 851 OHMS IT WAS REPORTED THE LEAD ISSUE WAS NOTED ABOUT A YEAR AGO. THE PATIENT WAS HAVING WORSE TREMOR CONTROL AND HAD MORE TROUBLE WALKING. THE PATIENT'S VISIT WITH THE HEALTH CARE PROFESSIONAL (HCP) WAS IN (B)(6) 2018 AND IT WAS NOTED THE PATIENT'S SYMPTOMS WERE GETTING WORSE WITH GAIT AND BALANCE THE LAST SEVERAL YEARS. IT WAS REPORTED THE PATIENT WAS ORIGINALLY PROGRAMMED CASE AND 3 AT 130HZ, 90PW AT 3.5 VOLTS. WHEN THE PATIENT WAS SWITCHED TO CASE AND 0, THE PATIENT EXPERIENCED DIPLOPIA, WITH CASE AND 1 THE PATIENT HAD BLURRY VISION. THE PATIENT WAS THEN PUT BACK TO THE ORIGINAL SETTING WITH C AND 3 AT 3.6 VOLTS. THE PATIENT WAS REFERRED TO THE HEALTH CARE PROFESSIONAL (HCP) FOR INS REPLACEMENT AND POSSIBLE LEAD REPLACEMENT. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586766 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602 00613994761057

    Patients

    Seq Age Sex Outcome Treatment
    1