BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3993755 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09141
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    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
    JA
    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. CONCOMITANT MEDICAL PRODUCTS: 429688 IMPLANTABLE PACING LEAD, (B)(6) 2013; 5076-52 IMPLANTABLE PACING LEAD, (B)96) 2007. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION; HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). ANALYSIS OF THE DEVICE MEMORY ALSO INDICATED THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WERE MET.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD SHORT INTERVAL COUNTS (SIC) AND NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODES. THE OVERSENSING WAS ASSOCIATED WITH THE PATIENT'S BREATHING AND A LEAD FRACTURE WAS SUSPECTED. DURING THE LEAD REVISION PROCEDURE, THE HELIX WOULD NOT RETRACT. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468027 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| R DTBB2D1 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR