BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 1990373 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-01953
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 8, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(6) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE DISTAL CONDUCTOR WAS DISTORTED, THE DEFIBRILLATOR CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE PROXIMAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THERE WAS HAD BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE OUTER INSULATION WAS MELTED, THE OUTER TUBING OVERLAY WAS MELTED, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER TUBING HAD A NON-ELECTRICAL ENVIRONMENTAL STRESS CRACKING BREACH/BREACH, THE OUTER TUBING WAS TORN, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS APPARENT EXPLANT DAMAGE. THE ANALYST NOTED THAT THE OUTER TUBING ENVIRONMENTAL STRESS CRACK BREACH IS NOT AN INSULATION BREACH. THE OUTER TUBING MELTING IS DUE TO EXPLANT DAMAGE. IT CANNOT BE DETERMINED AT THIS TIME HOW THE BLOOD ENTERED THE SVC LEG.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RIGHT VENTRICULAR LEAD HAD AN INSULATION BREACH. THE LEAD WAS PARTIALLY REMOVED AND THE REMAINING PORTION WAS CAPPED. A NEW RIGHT VENTRICULAR LEAD WAS IMPLANTED. 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. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD