BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1922673 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13031
    Event Type
    Injury
    Date Received
    December 13, 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
    GA, 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)(4): THE DISTAL PORTION OF THE LEAD WAS RETURNED, ANALYZED AND THE PROXIMAL CONDUCTOR WAS FRACTURED. IT WAS NOTED THAT THE DEFIBRILLATION CONDUCTOR WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER TUBING OVERLAY WAS BREACHED CUT, THERE WAS A WHITE SUBSTANCE ON THE EXPOSED DEFIBRILLATION COIL AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.

    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. 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 RIGHT VENTRICULAR (RV) LEAD WAS REMOVED PROPHYLACTICALLY DUE TO HIGH THRESHOLDS AND HIGH IMPEDANCE DURING A NORMAL PACEMAKER ERI CHANGE OUT. A NEW LEAD WAS IMPLANTED. DURING THE RV LEAD EXTRACTION, THE PATIENT EXPERIENCED A SUDDEN DROP IN BLOOD PRESSURE AND WAS SENT TO THE UNIT FOLLOWING THE PROCEDURE FOR OBSERVATION. NO FURTHER 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 68 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB