BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2053398 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04855
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 2, 2011
    Report Date
    September 19, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. THE DEVICE WAS EXPOSED TO AUTOMATED DIAGNOSTIC TESTS THAT VERIFIED THE PERFORMANCE OF PACING, SENSING AND RECORDING FUNCTIONS OF THE DEVICE AND NO ANOMALIES WERE FOUND. THIS DEVICE PERFORMED NORMALLY THROUGHOUT ANALYSIS, OPERATING AS DESIGNED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT NINE MONTHS LATER THE DEVICE WAS EXPLANTED DURING A REVISION PROCEDURE FOR THE NEW RV LEAD, IT HAS BEEN EXHIBITING LOSS OF CAPTURE. DURING THE REVISION PROCEDURE, THE PHYSICIAN WAS UNABLE TO GAIN ACCESS AND THE DEVICE AND LEADS WERE EXPLANTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE ELECTROGRAM SHOWED NOISE AND OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD AND PACING INHIBITION WAS OBSERVED ON THE HOLTER MONITOR. THE NOISE WAS NOT ABLE TO BE REPRODUCED AND THE PATIENT WAS EXPERIENCING DIZZY SPELLS. IT WAS NOTED THAT THIS TACHYCARDIA LEAD HAD BEEN IMPLANTED OFF LABEL IN A PACEMAKER SYSTEM . THE RV LEAD WAS EXPLANTED AND A NEW BRADYCARDIA LEAD WAS SUCCESSFULLY IMPLANTED. THE DEVICE REMAINS IMPLANTED IN THE PATIENT. NO ADVERSE PATIENT EFFECTS AS A RESULT OF THE LEAD REVISION PROCEDURE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S602

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R S602| 4136| 0185