BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 3210084 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07093
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 13, 2013
    Report Date
    May 15, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE IS EXPECTED TO BE RETURNED FOR LABORATORY ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    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. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE DEVICE REPLACEMENT PROCEDURE, A NEW SINGLE CHAMBER PACEMAKER WITH A 5/6MM HEADER WAS CONNECTED TO THE CHRONIC COMPETITIVE RIGHT VENTRICULAR (RV) LEAD. THE ABDOMINAL SYSTEM HAD ALWAYS EXHIBITED HIGH PACING THRESHOLDS, SO THE NEW PACEMAKER WAS PROGRAMMED TO 5.0V @ 1.0MS. AFTER THE PROCEDURE, THE PACING THRESHOLD MEASUREMENT HAD INCREASED SLIGHTLY AND THE PACING IMPEDANCE MEASUREMENT HAD DECREASED FROM 200 OHMS DOWN TO 130 OHMS. THE PATIENT EXPERIENCED TWITCHING WHEN THE DEVICE OUTPUT WAS PROGRAMMED AT 5.0V, SO THE OUTPUT WAS DECREASED TO 4.5V @ 1.0MS. THE FOLLOWING DAY, SEVERAL EPISODES OF PACING FAILURE HAD BEEN OBSERVED, AND THE PACING THRESHOLD MEASUREMENTS WERE NOW OVER 4V. THE PHYSICIAN ELECTED TO IMPLANT A NEW PECTORAL SYSTEM ON THE PATIENT¿S LEFT SIDE. A NEW IS-1 RV PACING LEAD WAS IMPLANTED AND THE CHRONIC COMPETITIVE RV LEAD WAS SURGICALLY ABANDONED. THE PACEMAKER WITH A 5/6MM HEADER WAS EXPLANTED AND AN IS-1 PACEMAKER WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309242 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S204

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R