BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 3050035 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-04612
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 21, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE REMOTE HOME MONITORING SYSTEM ISSUED AN ALERT FOR A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT ON THE RIGHT VENTRICULAR (RV) LEAD. SUBSEQUENTLY, THE PATIENT WAS BROUGHT BACK INTO THE LAB WHERE THE LEAD TESTED FINE WITH A PACING SYSTEM ANALYZER (PSA) THUS THE PHYSICIAN RE-INSERTED IT INTO THE DEVICE. UPON RE-INSERTION, NO FURTHER MEASUREMENT ISSUES WERE SEEN. THE PHYSICIAN BELIEVES THAT THERE WAS A CONNECTION ISSUE THAT HAS NOW BEEN RESOLVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149356 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N161

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R 1851| 0145| 4244| N161| MISMATCH| H217| T165