BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3071624 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05235
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. CONCOMITANT PRODUCTS: H217 COMPETITOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  IMPLANTED: (B)(6) 2007, 4542 COMPETITOR IMPLANTABLE PACING LEAD IMPLANTED: (B)(6) 2007, 4470 COMPETITOR IMPLANTABLE PACING LEAD (B)(6) 2007. (B)(4).

    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 PATIENT EXPERIENCED ENDOCARDITIS. IT WAS ALSO REPORTED THAT THE LEAD HAD FAILED. FOLLOW UP WAS ATTEMPTED AND NO FURTHER INFORMATION COULD BE OBTAINED. THE LEAD WAS EXPLANTED 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
    173163 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R