BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3015985 · Received March 21, 2013

    Report

    Report Number
    3004209178-2013-04090
    Event Type
    Injury
    Date Received
    March 21, 2013
    Report Date
    March 12, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION: PRODUCT ID 387345, LOT# V009263, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: SCREENING DEVICE: PRODUCT ID 3389S-40, LOT# V090728, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THERE WERE NO REPORTED ISSUES ON THIS DEVICE. THE PATIENT'S DEVICE REMAINS IMPLANTED AND THE ISSUES STATED IN THE INITIAL REPORT REFER TO THE PATIENT'S OTHER DEVICE. REFERENCE MANUFACTURER'S REPORT #3004209178-2013-04091 FOR ANY ADDITIONAL INFORMATION REGARDING THE PATIENT'S OTHER DEVICE.

    Description of Event or Problem · 1

    THE COMPANY REPRESENTATIVE REPORTED THAT ALL ELECTRODE PAIRS ON THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM HAD IMPEDANCES >40000 OHMS EXCEPT PAIR 2-3, WHICH WAS 1500 OHMS. THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND A REVISION SURGERY WAS PLANNED FOR THAT DAY. THE COMPANY REPRESENTATIVE BELIEVED THE PATIENT HAD A SURGICAL PROCEDURE SINCE RECEIVING THE INS, BUT THAT COULD NOT BE CONFIRMED. IT WAS LATER REPORTED BY THE COMPANY REPRESENTATIVE THAT REVISION SURGERY OCCURRED AND THE INS WAS CHECKED DURING SURGERY. THE INS WAS REMOVED AND THE EXTENSION IMPEDANCES WERE MEASURED AND FOUND TO BE WITHIN RANGE. THE CAUSE OF THE HIGH IMPEDANCES WAS DETERMINED TO BE A FAULTY INS AND THE INS WAS REPLACED. THE SYSTEM FUNCTIONED PROPERLY AFTER THE REPLACEMENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117775 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention