BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATCH

    MDR report key: 2911899 · Received January 11, 2013

    Report

    Report Number
    2124215-2013-00017
    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
    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
    16632 PATCH IMPLANTABLE LEAD NHW HISTORICAL CPI ST. PAUL 0040

    Patients

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