BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2812210 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15681
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 FOR: (B)(4) - THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE OUTER TUBING WAS KINKED/BUCKLED, THE OUTER TUBING OVERLAY HAD A COSMETIC ENVIRONMENTAL STRESS CRACK (ESC), THERE WAS A OUTER TUBING ENVIRONMENTAL STRESS CRACK (ESC) BREACH/BREACH (NON-ELECTRICAL), THE OUTER TUBING OVERLAY WAS BREACHED/CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM, THERE WAS APPARENT EXPLANT DAMAGE, THERE WAS A NON-ELECTRICAL MISCELLANEOUS FINDING ON THE TIP ELECTRODE AND THE LEAD WAS STRETCHED. PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND REVEALED THAT THERE WAS HIGH RESISTANCE/IMPEDANCE; 1 - PATIENT ALERT FOR RIGHT VENTRICULAR(RV) PACE LEAD Z = 1008 OHMS; WEEKLY AND DAILY PACE LEAD IMPEDANCE LOG DATA SHOWS AN INCREASE FOR MINIMUM AND MAXIMUM RV PACE = 400 TO 1008 OHMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD IMPEDANCE HAS STEADILY RISEN FROM APPROXIMATELY 500 OHMS TO 1000 OHMS, CAUSING THE LEAD INTEGRITY ALERT TO TRIGGER. IT WAS NOTED THAT THE THRESHOLD MAY HAVE RISEN AND THERE MAY BE A POTENTIAL LEAD FRACTURE. THE ALERT WAS RAISED TO 1500 OHMS AND A LEAD REVISION/EXTRACTION IS PLANNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WAS OUTER INSULATION DAMAGE UNDERNEATH THE SUTURE SLEVE. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R 5071 IMPLANTABLE PACING LEAD| 7303 IMPLANTABLE PACEMAKER/CARDIO/DEFIB