BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1072359 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03924
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    May 30, 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
    MO, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SUBSTANTIAL DROP IN LEAD IMPEDANCE, SO THE LEAD WAS REPLACED. WHEN THE NEW LEAD WAS ATTACHED TO THE DEVICE, OVERSENSING/NOISE ON THE VENTRICULAR PACE/SENSE CHANNEL OCCURRED. ATTEMPTS WERE MADE TO DISCONNECT AND RECONNECT THE LEAD, BUT IT COULD NOT BE RESOLVED. THEREFORE, THE DEVICE WAS ALSO 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 FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5076 IMPLANTABLE PACING LEAD