BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 2131723 · Received June 16, 2011

    Report

    Report Number
    6000144-2011-03535
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. EVALUATION SUMMARY FOR (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD HIGH IMPEDANCE AND THRESHOLDS THAT WERE HIGH, UNSTABLE/UNMEASURABLE. IT WAS FURTHER REPORTED THAT THE LEAD HAD A POSSIBLE FRACTURE. A CHANGE OUT OF THE LEAD WAS IN PROGRESS WHEN OVERSENSING WAS NOTED WHILE THE PATIENT'S CHEST WAS BEING SCRUBBED. A POSSIBLE SET SCREW AND CONNECTOR BLOCK PROBLEMS WERE ALSO NOTED TWO WEEKS AFTER THE INITIAL IMPLANT DATE. THE DEVICE WAS REMOVED AND REPLACED, AND THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURA DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D224DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD