BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1991395 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02375
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    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
    TX, 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 SPRINT FIDELIS LEAD, MODEL 6949, IS PART OF THE ADVISORY FOR THIS MODEL. ANALYSIS OF THE DEVICE 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. THE SPRINT FIDELIS LEAD, MODEL 6949, IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4): PROXIMAL SEGMENTS OF THE LEAD WERE RETURNED AND ANALYZED. PRIMARY RESULTS REVEALED THAT NO ANOMALIES WERE FOUND. THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED). IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION. (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED. PRIMARY RESULTS REVEALED THAT THE SHAFT SEAL WAS OUT OF POSITION. THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED) AND IN/ON THE HELIX/LOBE MECHANISM AND THE SLEEVE HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO EXPLANT THE 6949 RIGHT VENTRICULAR (RV) LEAD, BUT IT WAS NOT POSSIBLE TO INSERT A STYLET PAST THE SUBCLAVIAN. THE LEAD WAS CUT AND CAPPED, DUE TO PATIENT AGE AND CO-MORBIDITIES. A 6947 LEAD WAS THEN ATTEMPTED TO BE IMPLANTED AS A REPLACEMENT, BUT THERE WAS DIFFICULTY IN MANEUVERING THE LEAD, AND IT WAS NOT IMPLANTED. A SECOND 6947 LEAD WAS IMPLANTED AS THE REPLACEMENT FOR THE 6949 LEAD, AND IT WAS NOTED THAT THERE WAS DIFFICULTY DURING ITS IMPLANT. THE SECOND 6947 LEAD REMAINS IN USE. 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 89 YR Hospitalization| R 4194 IMPLANTABLE PACING LEAD| 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD