BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 3041216 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-03160
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 11, 2013
    Report Date
    December 6, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DISC ANALYSIS WAS PERFORMED IN WHICH THE FOLLOWING OBSERVATIONS WERE NOTED. THE DEVICE HAS NO RESETS AND NO MEMORY ERRORS. THE DEVICE WAS IMPLANTED 3.6 YEARS AGO. THE DEVICE IS OPERATING IN THE 2ND TO THE HIGHEST CURRENT BIN AND SHOULD BE INDICATING 30% REMAINING ON THE BATTERY INDICATOR. ACCORDING TO MERLIN CALL LOGS THE DEVICE HAD PREVIOUSLY BEEN PROGRAMMED TO LOWER SETTINGS AUTOMATIC CAPTURE (AC) WAS CONFIRMED TO BE PROGRAMMED ON. THE AC DATA SHOWS THE PACING THRESHOLDS TO BE AS HIGH AS 2.7 VOLTS (V) AND WITH THE 0.5V MARGIN ADDED IT GIVES 3.2V. WITH THE MOST RECENT PROGRAMMED SETTINGS OF SSIR XL+MV, LOWER RATE LIMIT (LRL) 70, 5.0V AT 0.5 MILLISECONDS (MS) THE ESTIMATED LONGEVITY IS 3.8 YEARS. ACCORDING TO THE DEVICE CURRENT REMAINING AND CURRENT USED CALCULATIONS THE DEVICE SHOULD HAVE ABOUT 1 YEAR REMAINING LONGEVITY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT IT IS CLINICAL DISCRETION IF THEY WANT TO CHANGE OUT LEAD AT NEXT DEVICE CHANGE-OUT, AS DO NOT KNOW IF AC/CAPTURE ISSUES WERE BECAUSE OF A LEAD ISSUE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS DEVICE WAS ELECTIVELY EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE CHECK 3 MONTHS PREVIOUS, THE DEVICE WITH A MAGNET RATE OF 100 BEATS PER MINUTE (BPM) SHOWED A BATTERY STATUS OF 4 YEARS REMAINING. DEVICE WAS CHECKED LAST MONTH, SHOWING SAME MAGNET RATE BUT WITH BATTERY STATUS OF 1.5 YEARS REMAINING. THERE WERE NO ADVERSE PATIENT EFFECTS. A REQUEST FOR DEVICE STATUS HAS BEEN SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT AT A LATER DATE THIS PATIENT PRESENTED TO THE EMERGENCY ROOM BECAUSE OF SYMPTOMS OF SYNCOPE HOWEVER NO LOSS OF CONSCIOUSNESS. DURING DEVICE EVALUATION IT WAS FOUND THAT THE PATIENT STATED THE AUTOMATIC CAPTURE (AC) WAS TURNED ON IN A PREVIOUS CLINIC VISIT, THE CALLER ALLEGED THAT THEY DON¿T THINK IT WAS WORKING AT THE TIME. A LOSS OF CAPTURE (LOC) WAS NOTED ON TELEMETRY PREVIOUSLY. PATIENT IS NOTED BEING DEPENDENT AND RECENTLY HAD AN AVN ABLATION. PACING AT THAT TIME SHOWED 100% CAPTURE. NOISE COULD BE REPRODUCED. THRESHOLDS HAVE BEEN HISTORICALLY HIGH. IMPEDANCES WERE STABLE. THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION. NO NON-CAPTURE WAS OBSERVED AND IMPEDANCES REMAINED STABLE. SENSITIVITY WAS ADJUSTED. THE DEVICE LONGEVITY REMAINING WAS FLUCTUATING AT THE TIME OF THE DEVICE EVALUATION. A SAVE TO DISC WAS PERFORMED AND SENT IN FOR ANALYSIS REVIEW BY BOSTON SCIENTIFIC TECHNICAL SERVICES (TS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142742 ALTRUA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND S601

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R 4055| 1270| 4054| S601