BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATCH

    MDR report key: 2161297 · Received July 13, 2011

    Report

    Report Number
    2124215-2011-10910
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NHW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN TROUBLESHOOTING, THE PHYSICIAN DID DO A COMMANDED SHOCK AFTER WHICH TIME SHOCK IMPEDANCE WAS ONCE AGAIN WITHIN NORMAL RANGE. THE PHYSICIAN SUSPECTED THAT CALCIFICATION ON THE LEAD TIP HAD BURNED OFF. THEN, MOST RECENTLY, SHOCK IMPEDANCE WAS VARIANT AGAIN, ALTHOUGH NEVER OUT-OF-RANGE. THE PHYSICIAN ELECTED TO SURGICALLY ABANDONED THIS RV LEAD AND EXPLANT THE ICD, WHICH IS PLANNED FOR RETURN TO BOSTON SCIENTIFIC.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD IN ASSOCIATION WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DID EXHIBIT VARIANCE IN SHOCK IMPEDANCE MEASUREMENTS. A CONDUCTOR ISSUE WAS SUSPECTED DUE TO THE AGE OF THE LEAD. HOWEVER, AT THE TIME OF THIS INITIAL REPORT, FURTHER TROUBLESHOOTING HAD NOT YET BEEN DONE. A MAXIMUM ENERGY SHOCK HAD NOT BEEN DONE TO TEST THE INTEGRITY OF THE DEVICE SYSTEM. THE SOURCE OF THE ISSUE WAS NOT YET KNOWN. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATCH IMPLANTABLE LEAD NHW HISTORICAL CPI ST. PAUL 0041

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention 0041| 0010| 1746| 1857| 1600| 1550