BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 1771534 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12709
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 11, 2010
    Report Date
    September 17, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED AS NECESSARY.

    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 LEAD ABRASION MARKS ON THE CASE.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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE DEVICE INTERROGATION, IT WAS NOTED THAT APPROXIMATELY ONE MONTH PRIOR, THE LEAD SAFETY SWITCH TRIPPED FOR THE RIGHT VENTRICULAR (RV) LEAD DUE TO IMPEDANCE MEASUREMENTS THAT WERE GREATER THAN 2500 OHMS. IT WAS ALSO NOTED THAT THE R WAVE AMPLITUDE MEASUREMENTS HAD DECREASED. A LEAD REVISION PROCEDURE WAS PERFORMED THREE DAYS LATER. DURING THE REVISION PROCEDURE, THE RV LEAD WAS CAREFULLY EXAMINED VIA FLUOROSCOPIC IMAGING AND AGAIN AFTER THE POCKET WAS OPENED. VISUAL INSPECTION DID NOT REVEAL ANY EVIDENCE OF INSULATION BREAK OR LEAD FRACTURE. THE PHYSICIAN DID NOTICE THAT THE RV LEAD WAS NOT PAST THE SECOND SET SCREW IN HEADER OF THE DEVICE. THE LEAD WAS TESTED USING THE PACING SYSTEM ANALYZER AND THE IMPEDANCE MEASUREMENTS CONTINUED TO VARY FROM 440 TO 1500 OHMS. THE PHYSICIAN OPTED SURGICALLY ABANDON THE EXISTING RV LEAD. A NEW LEAD WAS SUCCESSFULLY IMPLANTED WITH THE PREVIOUS DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE PACEMAKER WAS EXPLANTED OVER FIVE YEARS LATER DURING A THERAPY UPGRADE PROCEDURE WHERE THE PATIENT RECEIVED A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICE. THE PACEMAKER WAS RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R S603| 4470