BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 3242487 · Received July 23, 2013

    Report

    Report Number
    2649622-2013-08241
    Event Type
    Death
    Date Received
    July 23, 2013
    Report Date
    May 13, 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. THE INITIAL REPORTED EVENT WAS RECEIVED ON (B)(4) 2013. OF NOTE, THE REPORTABLE MALFUNCTION OF OVERSENSING AND OFF-LABEL USE IS NORMALLY SUBMITTED VIA A BIMONTHLY MEDWATCH REPORT SUBMISSION THAT SHOULD HAVE BEEN SUBMITTED ON (B)(4) 2013. INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(4) 2013 AND REVEALED THE PATIENT DIED. AS THERE IS NEW INFORMATION THAT REASONABLY SUGGESTS THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, THIS EVENT NO LONGER QUALIFIES FOR BIMONTHLY REPORTING AND IS THEREFORE BEING SUBMITTED AS A 30-DAY REPORT. ATTEMPT(S) FOR ADDITIONAL INFORMATION VIA THE PHYSICIAN OFFICE AND FUNERAL HOME WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. PRODUCT ID: D314TRG, IMPLANTED: (B)(6) 2012; PRODUCT ID: 419488, IMPLANTED: (B)(6) 2012; PRODUCT ID: 5024M-58, IMPLANTED: (B)(6) 1997. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS ALSO NOTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS CONNECTED TO THE RV LEAD PORT WHILE THE RV LEAD WAS CONNECTED TO THE LV PORT. IT WAS ALSO REPORTED THAT THERE WAS UNDERSENSING OF THE ATRIAL LEAD. A SEARCH OF THE MANUFACTURE DATABASE REPORTED THE PATIENT AS DECEASED TEN DAYS AFTER THE INITIAL REPORT. A CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343728 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Death