BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1922749 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13067
    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
    MN, 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) NO ANOMALIES WEREFOUND. THE FULL LEAD WAS RETURNED AND ANALYZED. ALL CONDUCTORS HAD BLOOD/BODY FLUID. (B)(4) NO ANOMALIES WERE FOUND. THE FULL LEAD WAS RETURNED AND ANALYZED. THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID, THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE /LOBE WAS DISTROTED/BENT, THERE WAS BLOOD IN/ON THE LOBE MECHANISM. ADDITIONALLY THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INAPPROPRIATE SHOCKS DUE TO A FRACTURE DEFIBRILLAITON LEAD. THE LEAD ALSO EXHIBITED OVERSENSING AND HIGH IMPEDANCE. DURING EXTRACTION OF THE LEAD THE HELIX WOULD NOT RETRACT SO THE LEAD WAS CAPPED AND REPLACED. IT WAS ALSO REPORTED THAT WHILE ATTEMPTING TO DELIVER THE LEFT VENTRICULAR LEAD THAT TWO LEADS WERE NOT ABLE TO BE PLACED DUE TO PATIENT ANATOMY. A THIRD LEAD WAS TRIED AND SUCCESSFULLY IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE 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 72 YR Hospitalization| R 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD