BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6041982 · Received October 19, 2016

    Report

    Report Number
    3004209178-2016-22127
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 28, 2016
    Report Date
    November 30, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    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 RECEIVED VIA A HEALTHCARE PROFESSIONAL (HCP) REPORTED A POWER ON RESET (POR) CODE WITH THE ERROR CODE 0X0008 LOW VOLTAGE ON (B)(6) 2016. IT WAS INDICATED THE PATIENT WAS TO CHECK HIS SYSTEM DAILY BUT HE HAD NOT DONE SO FOR A WHILE. THE PATIENT'S STIMULATION WAS ON CYCLING WITH 3 MINUTES ON/5 MINUTES OFF. THE PATIENT WOULD TURN STIMULATION OFF AND THEN ON AGAIN TO GET EXTRA STIMULATION IF THE PATIENT HAD A SEIZURE EVENT. NO SYMPTOMS WERE REPORTED. IT WAS NOTED THE IMPEDANCE ON THE LEFT SHOWED 500-1800 OHMS AND IMPEDANCE ON THE RIGHT SHOWED 400-1600 OHMS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE NEUROSTIMULATOR WAS REPLACED ON (B)(6) 2016. NO HOSPITALIZATIONS WERE RELATED TO THE EVENT. IT WAS NOTED THE OUTCOME WAS RESOLVED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    INFORMATION RECEIVED VIA A HEALTHCARE PROFESSIONAL (HCP) REPORTED A POWER ON RESET (POR) CODE WITH THE ERROR CODE 0X0008 LOW VOLTAGE ON (B)(6) 2016. IT WAS INDICATED THE PATIENT WAS TO CHECK HIS SYSTEM DAILY BUT HE HAD NOT DONE SO FOR A WHILE. THE PATIENT'S STIMULATION WAS ON CYCLING WITH 3 MINUTES ON/5 MINUTES OFF. THE PATIENT WOULD TURN STIMULATION OFF AND THEN ON AGAIN TO GET EXTRA STIMULATION IF THE PATIENT HAD A SEIZURE EVENT. NO SYMPTOMS WERE REPORTED. IT WAS NOTED THE IMPEDANCE ON THE LEFT SHOWED 500-1800 OHMS AND IMPEDANCE ON THE RIGHT SHOWED 400-1600 OHMS. IT WAS NOTED ELECTIVE REPLACEMENT INDICATOR (ERI) WAS SEEN ON THE CLINICAL PROGRAMMER. THE CALLER TRIED TO TURN STIMULATION ON (2 TIMES), BUT THE CLINICIAN PROGRAMMER WOULD NOT ALLOW HER TO AND IT WAS THROWING HER OUT OF THE PROGRAMMING SESSION. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS CHECKED AND IT SHOWED 2.220 V (CLOSE TO END OF SERVICE VOLTAGE). THERE WERE NO UNRELATED MEDICAL PROCEDURES RELATED TO THE EVENT AND THERE WAS NO REPORTED ALLEGATION/DISSATISFACTION REGARDING THE LONGEVITY OF THE INS. ADDITIONAL INFORMATION RECEIVED REPORTED THE BATTERY DEPLETION WAS CONSIDERED NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692062 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR