BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1072374 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03938
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    April 1, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    Z-0067-007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: NO ANOMALIES FOUND; FULL LEAD RETURNED AND ANALYZED. IT WAS REPORTED THAT THE 6949 LEAD HAD LOW IMPEDANCE AND NO CAPTURE. THE LEAD WAS EXPLANTED AND REPLACED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION DEVICE PERFORMED ACCORDING TO SPECIFICATIONS DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED CAPTURE, FAILURE TO MPEDANCE, LOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 6949 LEAD HAD LOW IMPEDANCE AND NO CAPTURE. THE LEAD WAS EXPLANTED AND REPLACED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5076 IMPLANTABLE PACING LEAD| D154AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB