BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 4895738 · Received July 7, 2015

    Report

    Report Number
    2124215-2015-08745
    Event Type
    Injury
    Date Received
    July 7, 2015
    Date of Event
    June 4, 2015
    Report Date
    July 14, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE 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). 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 THAT THIS DEVICE WAS UNABLE TO BE INTERROGATED. UPON TRYING AN ERROR MESSAGE POPPED UP AND WOULD ALLOW NO FURTHER INTERROGATION. THE PATIENT HAD UNDERGONE A SURGICAL PROCEDURE EARLIER IN THE WEEK AND A MAGNET WAS USED DURING THAT PROCEDURE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED THERE MIGHT BE AN ISSUE WITH A REED SWITCH AND GAVE SOME TROUBLESHOOTING TECHNIQUES. IF THOSE TROUBLESHOOTING TECHNIQUES DID NOT RESOLVE THE ISSUES, DEVICE REPLACEMENT WAS RECOMMENDED. THE DEVICE WAS EXPLANTED AND AT THE EXPLANT PROCEDURE, THE DEVICE WAS SUCCESSFULLY INTERROGATED. HOWEVER, THE DEVICE WAS EXPLANTED AND REPLACED. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440673 ALTRUA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R S603| 4136