BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 6168694 · Received December 13, 2016

    Report

    Report Number
    3004209178-2016-26303
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    November 30, 2016
    Report Date
    December 12, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 37603, SERIAL# (B)(4), PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3708640, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID 3708640, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE REPORTED A CONSUMER¿S SUBCLAVIAN POCKET WAS OPENED AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS CONNECTED TO THE ADAPTOR AGAIN. IMPEDANCES WERE MEASURED AND EXCEEDED 40000 OHMS USING ALL COMBINATIONS EXCEPT #0 COMBINATION. THE CONSUMER HAD DEVICES IMPLANTED ON BOTH SIDES, BUT ABNORMAL IMPEDANCE OCCURRED IN ONE SIDE ONLY. DEVICE SETTINGS WERE NOTED AS 2.4 MA, 60 US, 130 HZ/PPS, UNIPOLAR C+1-, AND 24 HOURS/DAY USAGE. IT WAS POSSIBLY CONSIDERED THAT THE SET-SCREW WAS TIGHTENED ONCE BUT WAS LOOSE WITHOUT DOING ANYTHING. HOWEVER, THE PHYSICIAN MENTIONED THAT THE PHYSICIAN MAY HAVE FORGET TIGHTENING THE SET-SCREW. AS THE PHYSICIAN WAS NOT SURE ABOUT IT, IT WAS UNKNOWN THAT THE EVENT WAS EITHER PRODUCT MALFUNCTION OR SURGICAL ERROR. WHEN SUBCLAVIAN POCKET WAS OPENED AND IT WAS CHECKED THAT THE INS WAS CONNECTED TO THE ADAPTOR, THE SET-SCREW WAS LOOSE AND THE ADAPTOR WAS DETACHED A BIT FROM THE INS. THE ADAPTOR WAS CONNECTED TO THE INS AND THE SET-SCREW WAS TIGHTENED ONCE AGAIN. AFTER THE SET-SCREW WAS TIGHTENED ONCE AGAIN, IT WAS CONFIRMED THAT THE ADAPTOR WAS COMPLETELY CONNECTED TO THE INS. THE WOUND SITE WAS CLOSED THEN. IMPEDANCES BECAME ALMOST NORMAL. THE ISSUE WAS NOTED AS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822922 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention