BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 3912526 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-13334
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 29, 2014
    Report Date
    March 13, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    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 TOOL MARKS ON THE HEADER AND BODY FLUID CONTAMINATION IN THE LEAD BARRELS. FURTHER INSPECTION FOUND THAT THE RA NEGATIVE SEAL PLUG HAD A CUT RUNNING THROUGH IT FROM TOP TO BOTTOM. ALL SEAL PLUGS WERE INTACT. 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 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).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER'S LONGEVITY AND MAGNET RATE HAVE BEEN AT <0.5 YEARS AND 90 RESPECTIVELY FOR THE PAST 7, AND HAS BROUGHT THE HEALTH CARE PROFESSIONAL (HCP) SOME FRUSTRATION WITH THE PATIENT NOT ENROLLED IN REMOTE MONITORING. THE PATIENT IS PACER DEPENDENT AND FOLLOW UP HAS BEEN INTENSIFIED. HOWEVER, BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SAID THAT THIS ICD DEVICE WAS NEARING ELECTIVE REPLACEMENT INDICATOR (ERI). THIS PACEMAKER DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER DEVICE SHOWED A MAGNET RATE OF 90 AND A BATTERY STATUS OF LESS THAN 0.5 YEARS REMAINING FOR 7 MONTHS. THIS HAD BROUGHT THE HEALTH CARE PROFESSIONAL (HCP) SOME FRUSTRATION WITH THE PATIENT NOT ENROLLED IN REMOTE MONITORING. THE PATIENT IS PACER DEPENDENT AND FOLLOW UP HAS BEEN INTENSIFIED. HOWEVER, BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SAID THAT THIS PACEMAKER DEVICE WAS NEARING ELECTIVE REPLACEMENT INDICATOR (ERI). THIS PACEMAKER DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THIS PACEMAKER DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION (NBD). NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389687 ALTRUA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND S403

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR S403| 4086| 1298| 4088