BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 1871680 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-18452
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 24, 2010
    Report Date
    October 28, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING SURGICAL INTERVENTION, THE SETSCREWS ON THE DEVICE HEADER WERE TIGHTENED. THIS SECURED LEAD-DEVICE CONNECTIONS WITH NO ADDITIONAL INTERVENTION REQUIRED. TO DATE, THE DEVICE REMAINS IMPLANTED AND IN SERVICE WITHOUT FURTHER COMPLICATIONS.

    Additional Manufacturer Narrative · 1

    A REVISION PROCEDURE HAS BEEN PLANNED. FOLLOWING REVISION PROCEDURE, THIS EVENT WILL BE FURTHER UPDATED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PACEMAKER MAY HAVE CONTRIBUTED TO HIGH, OUT-OF-RANGE PACING IMPEDANCE MEASUREMENTS. POST IMPLANT, IMPEDANCE VALUES WERE NOTED AROUND 500 OHMS BUT AT A RECENT FOLLOW-UP EXAM, APPROXIMATELY 3 MONTHS LATER, IMPEDANCE VALUES HAD INCREASED TO 2210 OHMS. NEITHER THE R-WAVES NOR THRESHOLDS HAD CHANGED DURING THAT TIMEFRAME. THE CLINICIAN WAS ABLE TO REPRODUCE THE HIGH IMPEDANCE VIA MANIPULATIONS; IN DOING SO, THE LEAD IMPEDANCE VARIED BETWEEN 500-2210 OHMS. ALSO, A LEAD FRACTURE WAS RULED OUT UPON X-RAY EXAMINATION, THUS A POTENTIAL CONNECTION ISSUE SUSPECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AND THE IMPLANTED LEAD IS A NON-BSC MODEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S201

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention