BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6158774 · Received December 9, 2016

    Report

    Report Number
    3007566237-2016-04335
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    November 14, 2016
    Report Date
    January 31, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    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

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE EXTENSION WAS TAKEN OUT AND WIPED WITH GAUZE, BUT THERE WERE STILL IMPEDANCE ISSUES. IT WAS ALSO REPORTED THAT THE ADAPTOR WAS SWITCHED, BUT THERE WERE STILL IMPEDANCE ISSUES. THE OLD BATTERY ALSO YIELDED IMPEDANCE ISSUES. IT WAS REPORTED THAT AT THIS POINT THE PHYSICIAN DECIDED TO CLOSE THE PATIENT SINCE THERE WAS NOTHING ELSE THEY COULD DO AT THAT POINT. IT WAS REPORTED THAT THE NEUROLOGIST WAS CONTACTED TO SEE IF IT COULD BE PROGRAMMED AROUND THE IMPEDANCE ISSUES. IT WAS NOTED THAT THE CAUSE WAS NOT DETERMINED. NO SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE PATIENT WAS HAVING THE IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED ON (B)(6) 2016. THE REP CHECKED IMPEDANCES PRIOR TO THE PROCEDURE AND NOTHING STOOD OUT AS AN ISSUE. A POCKET ADAPTOR WAS BEING USED AND ONCE THEY TESTED IMPEDANCES WITH THE ADAPTOR THE 0 <(>&<)> 3 COMBINATION SHOWED A POSSIBLE SHORT. IMPEDANCE MEASUREMENTS WERE TAKEN AND THE COMBINATION OF 0 <(>&<)> 3 WAS LESS THAN 50 OHMS. THEY TRIED WIPING DOWN THE SYSTEM AND THEY MIGHT HAVE TRIED ANOTHER ADAPTOR. THERE WERE NO ASSOCIATED SYMPTOMS. THE PATIENT¿S INDICATION(S) FOR USE WERE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814339 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR