BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2200624 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11029
    Event Type
    Injury
    Date Received
    August 11, 2011
    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
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): PROXIMAL CONDUCTOR FRACTURED, DEFIB CONDUCTOR FRACTURED AND DISTORTED, SEVERAL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED), DEFIB CONDUCTOR FRACTURE (OVERSTRESS), INNER INSULATION KINKED BUCKLED, OUTER TUBING OVERLAY MELTED AND COSMETIC ESC (ENVIRONMENTAL STRESS CRACKING) AND ESC BREACH/BREACH (NON-ELECTRICAL), OUTER INSULATION BREACHED CUT AND COSMETIC DEPRESSION, BLOOD IN/ON HELIX/LOBE MECHANISM. FULL LEAD IN SEGMENTS RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS EXPLANTED DUE TO AN INFECTION. THE LEAD WAS ANALYZED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. 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 70 YR Hospitalization| R 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5568 IMPLANTABLE PACING LEAD