BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2727380 · Received September 5, 2012

    Report

    Report Number
    3004209178-2012-07753
    Event Type
    Malfunction
    Date Received
    September 5, 2012
    Report Date
    August 7, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 748251, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION; PRODUCT ID: 748251, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION; PRODUCT ID: 7436, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID: 7428, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID: 3387S-40, LOT#: V021705, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID: 3387-40, LOT#: J0114193V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE TO CHANGE OUT THE PATIENT'S SYSTEMS FROM ONE PRODUCT FAMILY TO ANOTHER, HIGH IMPEDANCES ON CASE COMBINATIONS C0, C1, C2, AND C3 ON THE LEFT SIDE WERE DETECTED INTRAOPERATIVELY, MEASURING IN THE RANGE BETWEEN 5,500 AND 7,500 OHMS; ALL BIPOLE COMBINATIONS, HOWEVER, MEASURED IN NORMAL RANGE BETWEEN 1,000 AND 3,000 OHMS. THE TWO 1X4 ADAPTORS WERE WIPED DOWN AND RECONNECTED WITH NO RESOLVE. IT WAS NOTED THAT THE IMPEDANCES WERE REPORTED TO BE 'FINE' PRIOR TO SURGERY. IN ADDITION, IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IN THE POCKET DURING THESE IMPEDANCE MEASUREMENTS. YELLOW FLUID WAS DETECTED INSIDE THE PRONG OF THE EXTENSION AROUND THE SPRING CONTACTS. IT WAS INDICATED THAT EVEN AFTER A NEW ADAPTOR WAS USED, HIGHER IMPEDANCES WERE DETECTED ON THE CASE COMBINATIONS. CASE COMBINATIONS FOR THE RIGHT SIDE (C8-C11) WERE ALL WITHIN NORMAL LIMITS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IMPEDANCES WERE STILL HIGH AFTER REPROGRAMMING, BUT THE PATIENT WAS STILL RECEIVING THERAPY. THE PATIENT WAS REPROGRAMMED BY HER NURSE AND IT 'SEEMED TO DO WELL.' THERE WAS NO FURTHER INFORMATION TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1