BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 12771801 · Received November 8, 2021

    Report

    Report Number
    3004209178-2021-16607
    Event Type
    Malfunction
    Date Received
    November 8, 2021
    Date of Event
    April 28, 2021
    Report Date
    November 8, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MRU
    UDI-DI
    00643169864238
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT'S INS USAGE SHOWED (B)(6) 97%, (B)(6) NONE, (B)(6) 2021 86% (B)(6) NONE, (B)(6) 100, (B)(6) 90%. RECHARGE DATA SHOWED (B)(6) 26 MINUTES TO FULL, (B)(6), 4 HRS, (B)(6), 7.5 HOURS, (B)(6) - EACH TIME IT WAS FULL. LEFT 3+1-0- 3.2 130USEC 90HZ 2455 OHMS RIGHT C 8- 2.9 VOLTS 130USEC 90HZ 1393 3.98 WEEKS, 5.31 WEEKS EMPTY. THE MANUFACTURER REP WANTED TO KNOW WHY THERAPY WAS OFF THE LAST 2 TIMES PATIENT WAS IN HCP'S OFFICE, AND THEN TURNED STIMULATION ON. THE CALLER WAS NOT WITH THE PATIENT. REP SAID PATIENT HAD BEEN "TIGHTENING" UP. AFTER LOOKING AT PATIENT'S JSON FILE, IT APPEARS THERAPY WAS TURNED OFF ON (B)(6) AT 8:21:44 AND IT WAS NOT TURNED BACK ON UNTIL HCP INTERROGATED THE IMPLANT ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1667423 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M MRU MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00643169864238

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female