BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 5283894 · Received December 9, 2015

    Report

    Report Number
    2649622-2015-15660
    Event Type
    Injury
    Date Received
    December 9, 2015
    Date of Event
    October 9, 2015
    Report Date
    October 20, 2015
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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 EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA FROM THE DEVICE WAS COLLECTED AND ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER), THE UNEXPECTED DELIVERY OF A VENTRICULAR TACHYARRHYTHMIA THERAPY AND THE RIGHT VENTRICULAR (RV) LEAD INTEGRITY ALERT TRIGGERED. IT WAS NOTED BEGINNING (B)(6) 2015, VENTRICULAR SIC WERE UP TO 221994, ALONG WITH VENTRICULAR TACHYCARDIA (VT)-NON SUSTAINED (NS) EPISODES AND VENTRICULAR FIBRILLATION (VF) DETECTED EPISODES WITH INAPPROPRIATE SHOCKS DUE TO LEAD NOISE OVERSENSING. THE RV LEAD INTEGRITY WARNING OCCURRED ON (B)(6) 2015 FOR SIC GREATER THAN 30 IN THREE DAYS AND TWO OR MORE HIGH RATE NST EPISODES. CONCOMITANT PRODUCTS: 5076, LEAD, IMPLANTED: (B)(6) 2007. 4965, LEAD, IMPLANTED: (B)(6) 2007. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE PROXIMAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED MULTIPLE INAPPROPRIATE THERAPIES AND RIGHT VENTRICULAR (RV) LEAD OVERSENSING WAS OBSERVED, ALONG WITH HIGH IMPEDANCE AND A SUSPECTED LEAD FRACTURE. IT WAS NOTED A POTENTIAL CONNECTION ISSUE WITH THE DEVICE WAS SUSPECTED AND RV LEAD DETECTION WAS TURNED OFF. THE LEAD WAS LATER EXPLANTED AND INSULATION DAMAGE WAS OBSERVED BECAUSE THE LEAD HAD BEEN FIXATED WITHOUT AN ANCHORING SLEEVE. THE RV LEAD WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810716 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Hospitalization| L| R