BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1920619 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12316
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    August 26, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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: (B)(4) THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. DISTAL CONDUCTOR AND DEFIB CONDUCTOR WERE DISTORTED, DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), DISTAL CONDUCTOR FRACTURE (OVERSTRESS), INNER AND OUTER TUBING KINKED/BUCKLED, OUTER TUBING OVERLAY COSMETIC ESC, OUTER INSULATION COSMETIC CUT, HELIX/LOBE DISTORTED/BENT, BLOOD IN/ON HELIX/LOBE MECHANISM. APPARENT EXPLANT DAMAGE. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE LEAD "RUPTURED". THE LEAD WAS REMOVED AND REPLACED. NO FURTHER 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 82 YR Hospitalization| R 4194 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB