BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 9530578 · Received December 30, 2019

    Report

    Report Number
    3004209178-2019-24534
    Event Type
    Malfunction
    Date Received
    December 30, 2019
    Date of Event
    October 25, 2019
    Report Date
    February 25, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169864191
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DATE OF THE EVENT (B)(6) 2019 IS AN ESTIMATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) REPORTING THAT THEY HAD AN APPOINTMENT WITH THE SURGEON AND THEY DETERMINED THAT IT MAY BE A MUSCLE SPASM AS IT APPEARED TO BE BELOW THE INS. THE SURGEON RULED OUT THE INS AS THE CAUSE OF THE PATIENT'S DISCOMFORT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) REGARDING PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR ESSENTIAL TREMORS AND MOVEMENT DISORDERS. IT WAS REPORTED THAT SINCE PATIENT HAD GALLSTONE SURGERY ON (B)(6), THEY HAVE HAD SUDDEN INTERMITTENT "ZING" SENSATION BELOW THE BATTERY SITE. IT WAS ALSO STATED THAT THE PATIENT'S TREMOR HAS BECOME INCREASINGLY BOTHERSOME. REP SAID THERAPY WAS TURNED OFF FOR THE GALLSTONE PROCEDURE AND THEY THINKS LITHOTRIPSY WAS USED. PALPATION OF THE AREA GIVES THE ZINGING SENSATION AT TIMES BUT NOT OTHERS. REP ISN'T ABLE TO TURN THERAPY OFF TO TRY PALPATION, SINCE PATIENT CAN'T TOLERATE THERAPY BEING OFF. IMPEDANCE CHECK DIDN'T SHOW ANY APPARENT ISSUE WITH THE SYSTEM. LEFT SIDE PROGRAMMING 0- 1- 3+ C0 1375 OHMS C1 912 C2 804 C3 897 01 1792 02 1797 03 1931 12 1244 13 1451 23 1206 RIGHT SIDE PROGRAMMING 8- 9- 11+ C8 1345 OHMS C9 1255 C10 1160 C11 897 8<(>&<)>9 1788 8<(>&<)>10 2052 8<(>&<)>11 1857 10<(>&<)>9 1731 11<(>&<)>9 1726 11<(>&<)>10 1355 OHMS REP SAID IMPLANT BATTERY WAS STILL AT 2.9 SOMETHING VOLTS, AND THERE WAS NO APPARENT DRAIN. REP STATED THE HEALTH CARE PROVIDER (HCP) WAS THINKING OF REPLACING THE INS TO SEE IF THE ISSUE RESOLVES. REP INDICATED THAT THEY KNEW PATIENT HAD A PROBLEM WITH DEVICE ON TUESDAY, BUT DIDN'T KNOW WHAT IT WAS UNTIL YESTERDAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1326765 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169864191

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR