BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3151704 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05660
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 22, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. PRODUCT ID: D224DRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, IMPLANTED: (B)(6) 2011; EXPLANTED: (B)(6) 2013, 5076 IM PLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2005. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT ID: D224DRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, IMPLANTED: (B)(6) 2011; EXPLANTED: (B)(6) 2013, 5076 IM PLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2005. (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 A PACEMAKER DEPENDENT PATIENT EXPERIENCED SYNCOPE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD INHIBITION OF PACING AND THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS REPLACED PREMATURELY. ADDITIONAL INFORMATION WAS ATTEMPTED TO BE OBTAINED, HOWEVER, IT WAS NOT AVAILABLE. THE ICD WAS EXPLANTED AND REPLACED AND THE RV LEAD WAS CAPPED AND 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
    252369 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694958

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR Hospitalization| L| R