BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATCH

    MDR report key: 2911710 · Received January 11, 2013

    Report

    Report Number
    2124215-2013-00016
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NHW
    PMA / PMN Number
    P830060
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE CHANGE-OUT PROCEDURE TO A COMPETITOR'S DEVICE, THESE EPICARDIAL PATCHES WERE EVALUATED WITH A PACING SYSTEM ANALYZER (PSA). THE IMPEDANCE RESULTS WERE > 2000 OHM ON ONE PATCH AND THE OTHER MEASURED < 200 OHMS. THE FIELD REPRESENTATIVE DID NOT KNOW WHICH PATCH HAD WHICH RESULT AS HE WAS NOT DIRECTLY INVOLVED IN THE CASE. A SHOCK WAS THEN DELIVERED THROUGH THE NEW DEVICE, DONE IN THE PATCH TO PATCH OR COLD CAN CONFIGURATION, AND THE MEASURED IMPEDANCE VALUE WAS >200 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED WITH THE FIELD REPRESENTATIVE THAT HAVING A READING OF > 2000 OHMS, AND THEN A SHOCK LEAD IMPEDANCE OF > 200 OHMS, WERE OUT OF RANGE, AND POTENTIAL CAUSES WERE DISCUSSED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATCHES WERE SURGICALLY ABANDONED AND A NEW TRANSVENOUS LEAD WAS IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17440 PATCH IMPLANTABLE LEAD NHW HISTORICAL CPI ST. PAUL 0040

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| R 1420| 0040| 1520| MISMATCH| 0030| 1600| 1410