BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 1874850 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11582
    Event Type
    Injury
    Date Received
    October 19, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO ELEVATED SENSING INTEGRITY COUNT (SIC), WHICH INDICATES POSSIBLE OVERSENSING. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6943 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention 6940 IMPLANTABLE PACING LEAD| D284DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB