BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 3803244 · Received May 9, 2014

    Report

    Report Number
    2124215-2014-10520
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    February 28, 2013
    Report Date
    May 30, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    D970003/S106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, DETAILED MECHANICAL AND ELECTRICAL TESTING WAS PERFORMED ON THE DEVICE. THE DEVICE BATTERY STATUS WAS ERT. THE DEVICE FUNCTIONED NORMALLY THROUGHOUT TESTING. LABORATORY ANALYSIS DETERMINED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION; HOWEVER, THE ESTIMATED LONGEVITY REMAINING VALUE APPEARED TO DECREASE MORE QUICKLY THAN EXPECTED BETWEEN ROUTINE FOLLOW-UPS. FACTORS INFLUENCING THE ESTIMATED LONGEVITY REMAINING CALCULATION INCLUDE PACING RATE, AMPLITUDE, PULSE-WIDTH AND LEAD IMPEDANCE. ANY (EVEN SLIGHT) CHANGES IN THESE FACTORS WILL IMPACT THE BATTERY CONSUMPTION CALCULATION AND THEREFORE THE REMAINING LONGEVITY ESTIMATE. PLEASE NOTE THAT, DESPITE THE DROP IN ESTIMATED LONGEVITY REMAINING, THE ACTUAL BATTERY CONDITION DID NOT CHANGE SIGNIFICANTLY BETWEEN FOLLOW-UPS. IN SUMMARY, IT WAS DETERMINED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION, BUT DECLARED ERT EARLIER THAN PREVIOUSLY ESTIMATED. THE REPORTED CLINICAL OBSERVATIONS WERE NOT ABLE TO BE CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER AND RIGHT ATRIAL (RA) LEAD DISPLAYED A LEAD SAFETY SWITCH (LSS). THE PATIENT WAS SEEN IN CLINIC FOR FOLLOW UP. MULTIPLE IMPEDANCE MEASUREMENTS WERE SAMPLED AND WERE NORMAL. THE LSS FUNCTION WAS RESET. THE PATIENT WAS TO BE CONTINUE TO BE MONITORED. SUBSEQUENT INFORMATION WAS RECEIVED WHICH INDICATED AN ADDITIONAL LSS HAD BEEN TRIGGERED. NOISE WAS ALSO PRESENT. ISOMETRICS DID NOT REVEAL ANY CHANGES. TS RECOMMENDED THAT AN X-RAY BE PERFORMED. REQUESTS FOR ADDITIONAL INFORMATION WERE MADE BUT UNSUCCESSFUL. THERE WERE NO ADVERSE PATIENT EFFECTS. THE DEVICE AND LEAD REMAIN IN SERVICE.

    Description of Event or Problem · 1

    SUBSEQUENTLY THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281560 ALTRUA LWP GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 4087| 1290| 4086| S606