BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2121526 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-07803
    Event Type
    Injury
    Date Received
    June 13, 2011
    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
    OH, 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. EVALUATION SUMMARY: (B)(4) ANALYSIS OF THE FULL LEAD FOUND NO ANOMALIES. BLOOD WAS FOUND ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND A COSMETIC DEPRESSION. THERE WAS APPARENT EXPLANT DAMAGE AND THE LEAD WAS ALSO NOTED TO HAVE STRETCHED. (B)(4) ANALYSIS OF THE FULL LEAD FOUND NO ANOMALIES. BLOOD WAS FOUND ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED) AND IN/ON THE HELIX/LOBE MECHANISM. A COSMETIC DEPRESSION AND CUT WAS ALSO NOTED IN/ON THE OUTER INSULATION AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4) ANALYSIS OF THE FULL LEAD FOUND NO ANOMALIES. BLOOD WAS FOUND ON ALL THE CONDUCTORS (NOT OBSTRUCTED). (B)(4) THE DISTAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE DEFIBRILLATION CONDUCTOR WAS DISTORTED BLOOD/BODY FLUID WAS NOTED ON THE DISTAL CONDUCTOR AND OUTER TUBING OVERLAY. THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND WAS BREACHED CUT. THE OUTER INSULATION WAS BREACHED CUT. THE HELIX/LOBE WAS DISTORTED/BENT. BLOOD WAS NOTED IN/ON THE HELIX/LOBE MECHANISM AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO CAPTURE ON THE LEFT VENTRICULAR (LV) LEAD. THE LEAD WAS REMOVED. DURING IMPLANT ATTEMPT OF THE REPLACEMENT LV LEAD, THERE WERE HIGH THRESHOLDS AND INABILITY TO PASS THE LEAD THROUGH A STENOTIC AREA OF THE VEIN. THE LEAD WAS REMOVED AND REPLACED. IT WAS FURTHER REPORTED THAT THERE WERE HIGH THRESHOLDS AND LOW SENSING ON THE ATRIAL LEAD. THE LEAD WAS REMOVED AND REPLACED. DURING THE REPLACEMENT, THE RIGHT VENTRICULAR LEAD SHOWED LOW R WAVES. THE LEAD WAS REMOVED AND REPLACED. 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 81 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB