BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1791128 · Received August 10, 2010

    Report

    Report Number
    2649622-2010-07008
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    March 23, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S030
    Removal / Correction Number
    Z-0067-0070-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) PROXIMAL CONDUCTOR FRACTURED; FULL LEAD IN SEGMENTS WAS RECEIVED AND ANALYZED. EXPOSED SVC DEFIB CONDUCTOR WIRES FRACTURED AT 39.5CM AND 40 CM, AND WERE DISTORTED. SEVERAL CONDUCTORS WERE DISTORTED. THE OUTER TUBING WAS KINKED/BUCKLED, AND WAS MELTED. THE OUTER TUBING INSULATION IS TORN, THE LEAD IS STRETCHED, AND THERE WAS CLAVICLE-RIB DAMAGE.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO A LEAD FRACTURE ON THE SVC COIL, AS SEEN ON X-RAY, AND INCREASED IMPEDANCE. THE LEAD SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. 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 FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6948 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention