BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2911796 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16312
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 30, 2012
    Report Date
    February 12, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THE DEVICE REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED THAT THIS DEVICE HAS NOW BEEN EXPLANTED.AT THIS TIME THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LOGBOOK FOR THIS DEVICE HAS SHOWN EVIDENCE OF NOISE. THE NOISE COULD NOT BE REPRODUCED AND THRESHOLDS AND IMPEDANCES WERE GOOD. THE PHYSICIAN REQUESTED THE FIELD REPRESENTATIVE REPROGRAM THE DEVICE. FOLLOWING REPROGRAMMING, PAUSES WERE NOTED DURING THRESHOLD TESTING THOUGH THE PATIENT WAS NOT SYMPTOMATIC. THE DEVICE WAS REPROGRAMMED AGAIN AND THE PATIENT WILL BE CHECKED IN A FEW DAYS AND A POSSIBLE REVISION IS BEING CONSIDERED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS RECHECKED AND HAD NO SYMPTOMS. THE PATIENT WILL BE CHECKED AGAIN ON ANOTHER MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18825 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| L| R 1280| 4086| 4087| 1290