BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2201423 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11111
    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-0068-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): THE DISTAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR FRACTURED. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS FRACTURED, THE OUTER TUBING OVERLAY WAS MELTED, OUTER TUBING OVERLAY WITH COSMETIC ENVIRONMENTAL STRESS CRACK, OUTER TUBING OVERLAY WAS BREACHED CUT, THE HELIX WAS DISTORTED/BENT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND THE LEAD WAS FLEXED, WITHIN FIVE CENTIMETERS OF THE ANCHORING SLEEVE. 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.

    Description of Event or Problem · 1

    THE LEAD WAS REMOVED DUE TO AN INFECTION. THE LEAD WAS RETURNED, ANALYZED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. NO FURTHER 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. 6931 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R