BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 1854816 · Received October 5, 2010

    Report

    Report Number
    2649622-2010-09310
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    August 12, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 OVER THE PAST 24 HOURS, THE SENSING INTEGRITY COUNTER IS HIGH, PACING IMPEDANCE INCREASED, A HIGH NUMBER OF NON-SUSTAINED TACHYCARDIA EPISODES OCCURRED WITH SOME IN THE NON-PHYSIOLOGIC RANGE, THE LEAD INTEGRITY ALERT TRIGGERED, AND THERE IS A POSSIBLE LEAD FRACTURE. THE LEAD IS STILL IN USE. PER THE MANUFACTURER'S DEVICE IMPLANT DATABASE, A NEW PACE/SENSE LEAD WAS IMPLANTED IN THE RIGHT VENTRICLE. NO PATIENT COMPLICATIONS HAVE BEEN 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. 6945 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4194 IMPLANTABLE PACING LEAD