BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3951189 · Received July 22, 2014

    Report

    Report Number
    2124215-2014-10037
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    April 26, 2014
    Report Date
    April 26, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THIS PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE PACING LEAD IMPEDANCE AND LOSS OF CAPTURE (LOC). NO GREATER THAN TWO SECONDS ASYSTOLE WAS NOTED. ADDITIONAL INFORMATION WAS RECEIVED AND INDICATED THAT AN ACUTE INFLAMMATORY RESPONSE IN THE LEAD TIP OR TISSUE INTERFACE AREA WAS SUSPECTED. THE LEAD HAD HIGH PACING THRESHOLD MEASUREMENT AND NORMAL RANGE IMPEDANCE WITH PACING SYSTEM ANALYZER (PSA). NORMAL CONNECTIONS WAS ALSO NOTED. THE LEAD WAS EXPLANTED AND REPLACED. THE DEVICE WAS REPROGRAMMED AND REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428210 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K063

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R 4135| K063| 4136