BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 10189622 · Received June 24, 2020

    Report

    Report Number
    3004209178-2020-10947
    Event Type
    Injury
    Date Received
    June 24, 2020
    Date of Event
    May 27, 2020
    Report Date
    June 24, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169100770
    PMA / PMN Number
    P960009
    Adverse Event
    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.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BY A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT BEGAN EXPERIENCING WEAKNESS WITHIN THE LAST WEEK AND WAS ADMITTED. THE REP INTERROGATED THE INS AND IT WAS AT 2/76V WITH OK STATUS. THE PATIENT EXPRESSED CONCERN THAT WEAKNESS WAS RELATED TO INS DEPLETION AND THE PHYSICIAN WAS QUESTIONING THE SHORT DEVICE LONGEVITY. THE CALLER SAID THE INS WOULD BE REPLACED SOON. BELOW ARE THE INS DETAILS AND IMPEDANCES: LEFT STN: 4.2V, 60 PW, 190 RATE, 1086 OHMS, 3.8 MA RIGHT STN: 3.1V, 70 PW, 190 RATE, 1443 OHMS, 2.2 MA 24 HOURS/DAY CALCULATED ESTIMATION: ERI AT 2.49 YEARS, EOS AT 2.74 YEARS LEFT IMPEDANCE (IN OHMS): C-0 976 C-1 946 C-2 956 C-3 961 0-1 1068 0-2 1333 0-3 1432 1-2 1039 1-3 1307 2-3 1060 RIGHT IMPEDANCES (IN OHMS): C-8 1086 C-9 1051 C-10 1076 C-11 1102 8-9 1455 8-10 1658 8-11 1787 9-10 1321 9-11 1615 10-11 1438. THE CALLER MENTIONED THAT THEY HAD SIMILAR INSTANCES IN THE PAST WHICH HAVE ALREADY BEEN DOCUMENTED. ADDITIONAL INFORMATION WAS RECEIVED THAT TECH SERVICES WAS CONTACTED AND IT WAS DETERMINED THAT THIS DEVICE DID NOT HAVE PREMATURE LONGEVITY ISSUE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND IT WAS DECIDED TO REPLACE THE INS. THE INS WAS EXPLANTED ON (B)(6) 2020. THE DEVICE STATUS WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654879 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169100770

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization