BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA ICD

    MDR report key: 3905800 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11538
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 13, 2014
    Report Date
    October 3, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    PMA / PMN Number
    P960040/S235
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON REVIEW OF THE PHOTOS SENT, TECHNICAL SERVICES NOTED THAT THE HIGH VOLTAGE LEAD PINS APPEARED REVERSED IN THE HEADER. TECHNICAL SERVICES NOTED A CONCERN OF DEFIBRILLATION EFFECTIVENESS. THE PHYSICIAN DID NOT WANT TO DO A REVISION AND THUS ELECTED TO REPROGRAM THE SHOCK VECTOR. THE FIELD REPRESENTATIVE DISCUSSED AWAITING TO DISCUSS THE CASE WITH THE PHYSICIAN AND IF PROCEEDING WITH DEFIBRILLATION TESTING OR A REVISION PROCEDURE WAS NECESSARY. AT THIS TIME THE RIGHT VENTRICULAR LEAD AND DEVICE REMAIN IMPLANTED. UPON ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOTED THAT THE SHOCK VECTOR WAS REPROGRAMMED AND THE NORMAL FOLLOW UPS WERE SCHEDULED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION NOTED THAT AT THE MOST RECENT FOLLOW UP FLUID WAS SEEN COMING OUT OF THE DEVICE POCKET WOUND. THE PHYSICIAN REMOVED THE DRESSING AND INSPECTED THE WOUND BEFORE REPLACING WITH A NEW DRESSING. A POSSIBLE INFECTION WAS SUSPECTED BUT NOT CONFIRMED. NO FURTHER CHANGES WERE MADE TO THE SYSTEM. THE SYSTEM REMAINS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP AFTER A DEVICE CHANGE THE NIGHT BEFORE THE SHOCK CHANNEL SIGNALS ON THE ELECTROCARDIOGRAM WERE VERY SMALL. IT WAS NOTED THAT ON THE SIGNALS WERE LARGE ON THE SHOCK CHANNEL ON WIRELESS ELECTROCARDIOGRAM. AN INQUIRY WAS MADE TO TECHNICAL SERVICES FOR FURTHER REVIEW. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP AFTER A DEVICE CHANGE THE NIGHT BEFORE THE SHOCK CHANNEL SIGNALS ON THE ELECTROCARDIOGRAM WERE VERY SMALL. IT WAS NOTED THAT ON THE SIGNALS WERE LARGE ON THE SHOCK CHANNEL ON WIRELESS ELECTROCARDIOGRAM. AN INQUIRY WAS MADE TO TECHNICAL SERVICES FOR FURTHER REVIEW. NO ADVERSE PATIENT EFFECTS WERE REPORTED. UPON REVIEW OF THE PHOTOS SENT, TECHNICAL SERVICES NOTED THAT THE HIGH VOLTAGE LEAD PINS APPEARED REVERSED IN THE HEADER. TECHNICAL SERVICES NOTED A CONCERN OF DEFIBRILLATION EFFECTIVENESS. THE PHYSICIAN DID NOT WANT TO DO A REVISION AND THUS ELECTED TO REPROGRAM THE SHOCK VECTOR. THE FIELD REPRESENTATIVE DISCUSSED AWAITING TO DISCUSS THE CASE WITH THE PHYSICIAN AND IF PROCEEDING WITH DEFIBRILLATION TESTING OR A REVISION PROCEDURE WAS NECESSARY. AT THIS TIME THE RIGHT VENTRICULAR LEAD AND DEVICE REMAIN IMPLANTED. UPON ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED. IT WAS NOTED THAT THE SHOCK VECTOR WAS REPROGRAMMED AND THE NORMAL FOLLOW UPS WERE SCHEDULED. ADDITIONAL INFORMATION NOTED THAT AT THE MOST RECENT FOLLOW UP FLUID WAS SEEN COMING OUT OF THE DEVICE POCKET WOUND. THE PHYSICIAN REMOVED THE DRESSING AND INSPECTED THE WOUND BEFORE REPLACING WITH A NEW DRESSING. A POSSIBLE INFECTION WAS SUSPECTED BUT NOT CONFIRMED. NO FURTHER CHANGES WERE MADE TO THE SYSTEM. THE DEVICE WAS EXPLANTED AND RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383627 INCEPTA ICD IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION E161 103992

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R