BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2953109 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00929
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 14, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. 4086 COMPETITOR IMPLANTABLE PACING LEAD 2004 (B)(6); 4194 IMPLANTABLE PACING LEAD 2006 (B)(6). (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 LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED THE RIGHT VENTRICULAR (RV) LEAD WAS OVERSENSING WITH TWO LEAD FAILURE PREDICTOR HIGH RATE-NON SUSTAINED EPISODES LESS THAN EQUAL TO 215 MILLISECONDS AVERAGE V-CYCLE ON (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPEDANCE WAS OUT OF RANGE FOR THE RIGHT VENTRICULAR (RV) LEAD ON THE FIRST POST OPERATIVE CHECK. THE DEVICE WAS PROGRAMMED TO VOO AND DETECTIONS TURNED OFF. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE RV LEAD APPEARED TO HAVE NON-PHYSIOLOGICAL OVERSENSING AND THE ELECTROGRAM AND A SUSPECTED FRACTURE. THE RV LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56277 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694958

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR