BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 6289618 · Received January 31, 2017

    Report

    Report Number
    3004209178-2017-02131
    Event Type
    Injury
    Date Received
    January 31, 2017
    Date of Event
    December 22, 2016
    Report Date
    March 16, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    UDI-DI
    00613994761057
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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

    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

    ANALYSIS OF THE INS SERIAL NUMBER (B)(4) BATTERY WAS FOUND TO HAVE REACHED A NORMAL END OF LIFE. THE TELEMETRY AND OUTPUT WERE OKAY. 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.

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER (HCP) VIA THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE PATIENT GOT AN ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE ON (B)(6) 2016 AT 2.67, WITH SYMPTOMS NOT CONTROLLED AS WELL AS NORMAL. THE HCP INCREASED LEVODOPA AND SWITCHED TO BIPOLAR IN HOPES OF CONSERVING BATTERY AS A RESULT. THE PREVIOUS READING IN (B)(6) 2016 WAS 2.84, AND BY (B)(6) 2017 THE READING WAS 2.56, WITH A REPLACEMENT TAKING PLACE ON DATE NOTIFIED AND STILL READING AT 2.56. THE HCP FEELS THE DRAIN WAS TOO RAPID OVER THE YEAR EVEN THOUGH HISTORICALLY THE PREVIOUS BATTERIES HAVE LASTED THE SAME AMOUNT OF TIME. THE PROGRAMMED SETTINGS ARE AS FOLLOWS. GROUP A ACTIVATED (B)(6) 2016 0+2-3-, 3.3 V, 60 PW, 130 RATE, NORMAL IMPEDANCES RANGING FROM 850-110. GROUP B ACTIVATED (B)(6) 2012 TO -JUN 2016, 3.0 V, 60 PW, 110 RATE, SIMILAR IMPEDANCES TO GROUP A. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THE PATIENT'S INDICATION FOR IMPLANT IS PARKINSON'S DUAL AND MOVEMENT DISORDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72134 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602 00613994761057

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention