BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 6026778 · Received October 13, 2016

    Report

    Report Number
    2124215-2016-15302
    Event Type
    Injury
    Date Received
    October 13, 2016
    Date of Event
    July 5, 2016
    Report Date
    September 20, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    N970003/S132
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PACEMAKER WILL NOT BE AVAILABLE FOR RETURN. 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

    AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED AT THAT TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION OBTAINED FROM THE FIELD REPRESENTATIVE INDICATES THAT THE DEVICE JUST DISAPPEARED AND THE HOSPITAL MIGHT HAVE THROWN IT AWAY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER'S BATTERY SHOWED THREE YEARS REMAINING WHEN THE OUTPUT IS DECREASED. THIS PACEMAKER WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678861 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K173

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization| L| R 1270| 1298| 4034| 4460| 4461| 7741| K173| L300| S603