BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2201421 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11110
    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

    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) THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. HOWEVER, THE DEFIBRILLATOR CONDUCTOR WAS DISTORTED AND THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE OUTER TUBING OVERLAY HAD A WHITE SUBSTANCE, BLOOD/BODY FLUID, COSMETIC ENVIRONMENTAL STRESS CRACKING, AND WAS MELTED. THE INNER INSULATION WAS TORN AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. THERE WAS A TIP ELECTRODE ISSUE (NON-ELECT) AND THE LEAD WAS STRETCHED. VISUAL ANALYSIS REVEALED APPARENT EXPLANT DAMAGE. THE LEAD WAS RECEIVED AT ANALYSIS WITH THE STEROID RING MISSING. IT CANNOT BE DETERMINED AT THIS TIME WHEN THIS OCCURRED. THERE IS ONLY ONE SET OF SETSCREW MARKS ON THE IS-1 PIN AND IT IS TOO PROXIMAL. THE LEAD WAS NOT FULLY INSERTED INTO THE DEVICE.

    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD AN INCREASE IN THRESHOLDS WITH REDUCED R-WAVE AMPLITUDE. THE LEAD WAS EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ASKU.

    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