BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6052463 · Received October 24, 2016

    Report

    Report Number
    3004209178-2016-22426
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Date of Event
    September 19, 2016
    Report Date
    October 24, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR PARKINSON'S TREMOR. IT WAS REPORTED THAT ON (B)(6) 2016 THE PATIENT'S RIGHT IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED. IT WAS STATED THAT A MANUFACTURERS' REPRESENTATIVE INFORMED THE DOCTOR DURING THE PROCEDURE THAT THE ALREADY IMPLANTED LEFT INS WOULD NOT NEED TO BE TURNED OFF FOR ELECTROCAUTERY. CALLER REPORTS PATIENT WAS SEEN IN (B)(6) 2016, LEFT INS BATTERY VOLTAGE WAS 2.94V, BY (B)(6) 2016, INS VOLTAGE WAS 2.884V WITHOUT PROGRAMMING CHANGES. THE HEALTHCARE PROVIDER ADDED THAT THE PATIENT CALLED THEM ON (B)(6), AND REPORTED THAT THEY HAD NOT BEEN FEELING WELL OVER THE WEEKEND, THEIR RIGHT SIDE WAS LOSING BENEFITS, THEIR DYSTONIA WAS A LOT WORSE BY 3 PM, THEIR RIGHT FOOT DYSTONIA HAD RETURNED, AND AN OOR MESSAGE WAS SEEN ON THEIR PATIENT PROGRAMMER. CALLER REPORTS THAT THE PATIENT CAME IN THAT EVENING AND UPON INTERROGATION WITH THEIR PHYSICIAN PROGRAMMER, NO OOR MESSAGE WAS SEEN. THEY REPORTED THAT THE HISTORY INDICATED THAT THE INS WAS OFF THAT DAY FROM 11:45-12:30PM AND THE PATIENT WAS NOT USING THEIR PROGRAMMER DURING THAT INCIDENT. IMPEDANCE INTERROGATED AT 3V: CO: 1101 OHMS C1: 1090 OHMS C2: 1361 OHMS C3: 5229 OHMS 01: 1586 OHMS 02: 2137 OHMS 03: 6254 OHMS 12: 1680 OHMS 13: 5558 OHMS 23: 3992 OHMS LEFT GPI PROGRAMMED: C+2- 1.7V/90PW/130HZ. THERAPY IMPEDANCE 1472 OHMS. CALLER REPORTS PATIENT HAS ALWAYS BEEN PROGRAMMED CV, HAS NEVER BEEN PROGRAMMED WITH CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701111 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR