BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3152754 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05688
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0068-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT: 7232CX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (B)(6) 2006. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE DISTAL AND PROXIMAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. THE DISTAL CONDUCTOR BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS. THE RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE AND OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED STRETCHING, THERE WAS ONE PATIENT ALERT FOR RV. PACE IMPEDANCE EQUAL TO 2992 OHMS ON (B)(6) 2013. WEEKLY PACE LEAD TREND DATA SHOWS AN INCREASE IN IMPEDANCE FROM 496 TO A PEAK OF 3360 OHMS BETWEEN (B)(6) 2013. TWENTY-TWO NON-SUSTAINED VENTRICULAR EPISODES OF 210 MILLISECONDS (MS) BETWEEN (B)(6) 2013. THREE VENTRICULAR FIBRILLATION WITH AN AVERAGE VENTRICULAR CYCLE OF 200 MS BETWEEN (B)(6) 2013. VENTRICULAR SHORT INTERVAL COUNT EQUAL TO 15040 COUNTS IN 7.94 DAYS, BETWEEN (B)(6) 2013. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, AND RETURNED PRODUCT TESTING FOUND THE DEVICE DID PERFORM AS DESCRIBED IN THE FIELD ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH IMPEDANCE, A HIGH NUMBER OF SHORT INTERVALS, AND SEVERAL EPISODES WITH ARTIFACT. THE LEAD WAS EXPLANTED AND REPLACED. DURING THE EXTRACTION PROCEDURE THE PHYSICIAN STATED THE STYLET WAS IMPOSSIBLE TO INSERT THROUGH THE LEAD AND WIRE EXTERNALIZATION WAS SEEN AFTER THE LEAD EXTRACTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254467 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693165

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Hospitalization| R