BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1925693 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14007
    Event Type
    Injury
    Date Received
    December 14, 2010
    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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE LEADS IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): A PARTIAL LEAD IN SEGMENTS WAS RETURNED AND ANALYZED. ANALYSIS RESULTS REVEALED THAT NO ANOMALIES WERE FOUND. BLOOD/BODY FLUID WAS PRESENT ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), ON THE OUTER TUBING OVERLAY, AND IN/ON THE HELIX MECHANISM. THE DISTAL CONDUCTOR WAS DISTORTED. THE INNER TUBING WAS KINKED/BUCKLED. THE OUTER TUBING OVERLAY WAS MELTED, BREACHED CUT, AND HAD COSMETIC ENVIRONMENTAL STRESS CRACKS. THE OUTER INSULATION WAS TORN AND HAD A COSMETIC DEPRESSION. THERE WAS A WHITE SUBSTANCE ON THE EXPOSED DEFIB COIL. THERE WAS APPARENT EXPLANT DAMAGE. THE LEAD IS PART OF THE ADVISORY FOR THIS MODEL. (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS RESULTS REVEALED THAT NO ANOMALIES WERE FOUND. BLOOD/BODY FLUID WAS PRESENT ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED). THE OUTER INSULATIONS WAS MELTED, HAD COSMETIC METAL INDUCED OXIDATION, COSMETIC ENVIRONMENTAL STRESS CRACKS, AND A COSMETIC DEPRESSION. THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD'S OUTER INSULATION WAS PEELING BACK AND THE LEAD WAS COILED TIGHTLY IN THE POCKET. THE LEAD WAS REMOVED AND REPLACED. THE LEFT VENTRICULAR LEAD HAD BEEN PROGRAMMED OFF SHORTLY AFTER IMPLANT 5 YEARS AGO DUE TO NO CAPTURE AND APPARENT DISLODGEMENT. IT WAS REMOVED AND REPLACED AT THE SAME TIME AS THE RIGHT VENTRICULAR LEAD AND ROUTINE DEVICE CHANGE OUT. 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 73 YR Hospitalization| L| R 4076 IMPLANTABLE PACING LEAD| 7304 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4076 IMPLANTABLE PACING LEAD| 7304 IMPLANTABLE PACEMAKER/CARDIO/DEFIB