BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 7802194 · Received August 21, 2018

    Report

    Report Number
    3004209178-2018-18775
    Event Type
    Injury
    Date Received
    August 21, 2018
    Date of Event
    August 13, 2018
    Report Date
    September 27, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529786
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    PRODUCT ID 37601, SERIAL# (B)(4) IMPLANTED: (B)(6) 2018. PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID 3389S-40, LOT# VA0YQQD, IMPLANTED: (B)(6) 2015. PRODUCT TYPE LEAD. 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 PROVIDER (HCP) REGARDING A PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE TREATMENT OF DYSTONIA AND MOVEMENT DISORDERS. IT WAS REPORTED THE PATIENT HAD A PARTIAL RETURN OF DYSTONIA SYMPTOMS STARTING 4 DAYS PRIOR AND THEN ESCALATING EARLIER TODAY. THE CALLER STATED THE PATIENT DID NOT HAVE A FULL RETURN OF SYMPTOMS BUT IT WAS BAD ENOUGH THAT THEY WERE WOULD BE ADMITTED ON THE EVENING OF THE CALL TO MANAGE HIS SYMPTOMS. IT WAS REPORTED THE PATIENT WAS MORE AFFECTED ON THE RIGHT SIDE OF HIS BODY. LEFT INS IMPEDANCES AT 3 V WERE: C-O: 2478 C-1: 1111 C-2: 1052 C-3: 3182 01: 2189 02: 2789 03: 4852 12:1356 13: 3507 23: 2514 IT WAS REPORTED THE LAST IMPEDANCE MEASURED ON (B)(6) 2018 WERE ALL NORMAL RANGE AND LOWER THAN SOME OF THE CURRENT VALUES. IT WAS REPORTED THE LEADS IN THE GLOBUS PALLIDUS INTERNUS WERE BEING USED WITH PROGRAMMING BUT THEY ALSO PLACED SUBTHALAMIC LEADS IN THE PAST TO BE A SECOND OPTION FOR PROGRAMMING BUT THESE LEADS HAD NEVER BEEN USED. IT WAS REPORTED THE PATIENT USED C-2 FOR PROGRAMMING AND HAD ALWAYS USED THIS PAIR AND IT HAD GIVEN THE PATIENT GOOD BENEFIT. THE CALLER REPORTED THEY WOULD CHECK ELECTRODE IMPEDANCES ROUTINELY TO SEE IF IT REVEALED A SHORT OR OPEN AND POSSIBLY CONSIDER PROGRAMMING THE STN LEADS. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HCP STATING THE CAUSE OF THE HIGH IMPEDANCES AND RETURN OF SYMPTOMS WAS DUE TO A FRACTURED LEFT CRANIAL LEAD IN THE GPI. NEUROLOGICAL REIMPLANTATION OCCURRED AND THE HIGH IMPEDANCES/RETURN OF SYMPTOMS HAD BEEN RESOLVED AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642377 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169529786

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization| R