BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2124215-2011-20857

    MDR report key: 2414108 · Received January 12, 2012

    Report

    Report Number
    2124215-2011-20857
    Event Type
    Injury
    Date Received
    January 12, 2012
    Date of Event
    December 15, 2011
    Report Date
    December 15, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 VIA THEIR INTERNAL LITERATURE REVIEW PROCESS, THAT SIX PATIENTS IMPLANTED WITH BOSTON SCIENTIFIC ICD/CRT-D DEVICES, EXHIBITED HIGH DEFIBRILLATION THRESHOLD (DFT) VALUES, DURING PRE-HOSPITAL DISCHARGE (PHD) TESTING. THIS STUDY WAS AIMED TO REVIEW THE RELEVANCE OR ADDITIONAL BENEFITS, OF PRE-HOSPITAL DISCHARGE TESTING POST ICD/CRT-D IMPLANT. RETROSPECTIVE DATA WAS COLLECTED AND ANALYZED FROM OVER 800 PATIENTS. WHILE NO SEVERE COMPLICATIONS WERE REPORTED, SIX PATIENTS WITH BOSTON SCIENTIFIC DEVICES, FAILED DFT PHD TESTING. OF THE SIX REPORTED FAILURES, THREE PATIENTS RECEIVED A SUB Q ARRAY FOR HIGHER ENERGY DELIVERY WHILE THE REMAINING PATIENTS, ACHIEVED SUCCESSFUL RESOLUTION BY REVERSING SHOCK POLARITY. NO ALLEGATIONS THE BOSTON SCIENTIFIC IMPLANTED DEVICES MALFUNCTIONED AND THE STUDY CONCLUDED, THAT TESTING AN IMPLANTED ICD FUNCTION AT LEAST ONCE IS RECOMMENDED AND CONSIDERING CERTAIN PATIENT CHARACTERISTICS, PDH TESTING WOULD BE ADVISABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LWS GUIDANT PUERTO RICO BV TACHY DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R