BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA PC

    MDR report key: 2063780 · Received April 15, 2011

    Report

    Report Number
    9614453-2011-02846
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 27, 2011
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MFR EMPLOYEE. TRAINING IS IN PLACE. ANALYSIS: 3387-V448143--NO SIGNIFICANT ANOMALIES. IN THE RETURNED MEDIAL SEGMENT OF THE LEAD, THREE OF THE FOUR CONDUCTORS ARE SHORTED WHERE THERE ARE SUSPECTED TOOL MARKS IN THE OUTER INSULATION AND THE CONDUCTORS COILS ARE CRUSHED APPROX 10 CM FROM THE DISTAL END (SUSPECTED EXPLANT DAMAGE). THE CONTINUITY IS ACCEPTABLE ON ALL CIRCUITS ON ALL THREE SEGMENTS OF THE RETURNED LEAD. THERE ARE NO SHORTS BETWEEN CIRCUITS (DAY) ON THE RETURNED PROXIMAL AND DISTAL SEGMENTS. THERE IS A SHORT BETWEEN THREE OF THE FOUR CIRCUITS IN THE MEDIAL SEGMENT RETURNED.

    Description of Event or Problem · 1

    REC'D INFO THE PT PROGRAMMER WAS USED TO CHECK THE IMPEDANCE OF THE DEVICE AND IT REPORTED 4 ELECTRODES OKAY AS OPPOSED TO 8. THE PHYSICIAN PROGRAMMER WAS THEN USED TO INTERROGATE THE DEVICE AND IT REPORTED THAT ONE SIDE HAD IMPEDANCES READINGS >40,000 OHMS AT 3V. ALL THE CONNECTIONS WERE CHECKED AT THE INS/EXTENSION SITE AS WELL AS THE LEAD/EXTENSION SITE. THE READINGS STILL CAME BACK > 40,000. EACH BRAIN LEAD WAS CHECKED INDIVIDUALLY USING THE TWIST LEAK SCREENING CABLE AND INITIALLY REPORTED ONE HIGH IMPEDANCE READING ON CONTACT 3 OF ONE LEAD BUT WHEN CHECKED AGAIN LATER IT WAS NORMAL. THE OTHER BRAIN LEAD WAS NORMAL. ONCE PROGRAMMING STARTED THE PHYSICIAN COULD NOT ILLICIT ANY THERAPEUTIC BENEFIT USING CONTACT 9, 10 AND 11 ON ONE SIDE. THE PHYSICIAN DECIDED ONE LEAD WAS NOT WORKING AND WOULD NEED TO BE REPLACED. THE LEAD WAS REPLACED AND THE PT PROGRAMMER USED AGAIN TO CHECK THE LEAD CONNECTIONS AND REPORTED ONLY 4 WERE OKAY. THE EXTENSIONS WERE THEN SWAPPED AROUND AT THE INS SITE AND IT REPORTED 8 OKAY. NO PT INJURY WAS REPORTED AND THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC MHY MEDTRONIC EUROPE SARL 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| LEAD: MODEL 3387, LOT# 0204157033| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387, LOT# V448143| EXTENSION: MODEL 37085, LOT# NKN003620V| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN005308V| EXPLANTED:| EXPLANTED: