BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 10350614 · Received July 31, 2020

    Report

    Report Number
    3004209178-2020-13224
    Event Type
    Malfunction
    Date Received
    July 31, 2020
    Date of Event
    March 13, 2020
    Report Date
    July 31, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00763000175719
    PMA / PMN Number
    P960009
    Product Problem
    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 SINCE THE PATIENT'S INS REPLACEMENT, THE PATIENT HAD BEEN HAVING ISSUE WITH IMPEDANCE READINGS. THE LEFT STN WAS PROGRAMMED WITH CONTACTS 0-1-2+. THE IMPEDANCES ARE LISTED BELOW: C/3: 2476 OHMS C/0: 1243 OHMS C/1: 1158 OHMS C/2: 1066 OHMS 0/3: 3190 OHMS 0/2: 1807 OHMS 0/3: 1508 OHMS 0/1: 1508 OHMS 1/2: 1451 OHMS 1/3: 2935 OHMS 2/3: 2265 OHMS THE RIGHT STN WAS AT 8-11+ WITH IMPEDANCES LISTED BELOW: C/8: 836 OHMS C/9: 830 OHMS C/10: 805 OHMS C/11: 805 OHMS 8/9: 96 OHMS 8/10: 1036 OHMS 8/11: 1053 OHMS 9/10: 1033 OHMS 9/11: 1045 OHMS 10/11: 210 OHMS AN X-RAY WAS SUGGESTED AND IT WAS SUGGESTED TO CHECK IMPEDANCES IN DIFFERENT POSITIONS. NO SYMPTOMS WERE REPORTED. THE REP CONFIRMED THERE WAS LOW IMPEDANCE ON 2 CONTACTS. SHE THINK IT OCCURRED DURING THE REPLACEMENT SURGERY. THE PATIENT WAS GOING TO BE PROGRAMMED AROUND THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815341 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00763000175719

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR