BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 3213116 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09785
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 2, 2013
    Report Date
    November 17, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, LEAD SEAL WITNESS MARKS INDICATE THAT THE DEFIBRILLATION LEAD WAS SLIGHTLY UNDER INSERTED BUT INSERTED FAR ENOUGH INTO THE PORT FOR THE SETSCREW TO MAKE CONTACT WITH THE LEAD TIP. ALL OTHER WITNESS MARKS INDICATE THAT THE REST OF THE LEADS WERE FULLY INSERTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT-OF-RANGE (OOR) SHOCK LEAD IMPEDANCE VIA THE PATIENT¿S MONITORING SYSTEM. THIS IS AN ON-GOING ISSUE; THE PATIENT IS CONTINUOUSLY MONITORED AT THIS TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S HOME MONITORING EQUIPMENT DETECTED A HIGH OUT OF RANGE SHOCKING IMPEDANCE FOR THIS PATIENT'S RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS BROUGHT IN FOR EVALUATION AND ISOMETETRICS WERE PERFORMED WHICH COULD NOT ILLICIT ANY ADDITIONAL OUT OF RANGE MEASUREMENTS. THE PHYSICIAN PLANS TO MONITOR THE LEAD FOR NOW. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED. THE DEVICE AND RV LEAD WERE EXPLANTED DUE TO INCREASED SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS RETURNED FOR RELIABILITY ANALYSIS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT DEFIBRILLATION THRESHOLD (DFT) TEST WAS PERFORMED ON THIS PATIENT A DAY PRIOR TO THE DETECTION OF ANOTHER OOR SLI MEASUREMENT. THE PHYSICIAN WILL FURTHER INVESTIGATE WITH THE CLINIC. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314444 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND N161

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R 4538| 4470| H210| 4136| 0185| N161