BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2812068 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16904
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    January 16, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S030
    Removal / Correction Number
    Z-0069-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4): THE MEDIAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THERE WAS COSMETIC ENVIRONMENTAL STRESS CRACKING OF THE OVERLAY TUBING, THERE WAS BLOOD INGRESSION OF THE OVERLAY TUBING, THE DEFIBRILLATION RIGHT CONDUCTOR WAS PULLED/STRETCHED/OVERSTRESSED, THERE WAS BLOOD ON THE DISTAL AND PROXIMAL CONDUCTORS (NOT OBSTRUCTED): THE OVERLAY TUBING, RIGHT VENTRICULAR AND SUPERIOR VENA CAVA DEFIBRILLATION CONDUCTORS WERE KINKED/BUCKLED, THERE WAS BLOOD ON THE DISTAL ELECTRODE, THERE WAS BLOOD ON THE DEFIBRILLATION CONDUCTOR, THE OVERLAY TUBING WAS BREACHED CUT, THE OVERLAY TUBING WAS MELTED, THE LEAD WAS STRETCHED AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND ENDOCARDITIS. THE LEAD WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND ENDOCARDITIS. THE LEAD WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6948

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R