BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 4140389 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17265
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    July 28, 2014
    Report Date
    October 21, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED. ONCE THE DEVICE IS RETURNED THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT EXPERIENCED A SYNCOPAL EVENT, WHICH LED TO THE PATIENT FALLING AND BREAKING BOTH OF THEIR LEGS AS A RESULT. THE INITIAL ATTEMPT TO INTERROGATE WAS UNSUCCESSFUL, HOWEVER, A NEW PROGRAMMER WAS USED AND INTERROGATION WAS SUCCESSFUL. THE PATIENTS DEVICE WAS INTERROGATED WHICH FOUND SOME VENTRICULAR TACHYCARDIA (VT) EVENTS, AS WELL AS NOISE THAT INHIBITED PACING FOR AN UNKNOWN DURATION. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED TRYING ISOMETRICS TO ILLICIT NOISE WHICH WAS DONE, NO NOISE WAS NOTED BUT OVERSENSING WAS SEEN. AS A RESULT, THE RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED AND THE DEVICE WAS EXPLANTED AND BOTH WERE SUCCESSFULLY REPLACED. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618103 ALTRUA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND S602

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R S602| 4137| 4136