BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1832990 · Received September 14, 2010

    Report

    Report Number
    2649622-2010-08989
    Event Type
    Death
    Date Received
    September 14, 2010
    Date of Event
    August 17, 2010
    Report Date
    February 27, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINIC THAT A CARELINK "RED ALERT TRANSMISSION" OCCURRED AT 440AM ON (B)(6) 2010 FOR THE NUMBER OF SHOCKS DELIVERED IN AN EPISODE. IT WAS NOT RECEIVED BY THE CLINIC UNTIL AFTER 4PM THAT SAME DAY. "THERE WAS A PHONE LINE ISSUE THAT PREVENTED THE MONITOR FROM CONNECTING TO THE NETWORK." THE CLINIC REPORTED THAT THE PATIENT HAD EXPIRED. THERE IS NO ALLEGATION FROM THE HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. FOLLOW UP REVEALED THE PATIENT "WAS A SICK MAN" AND THE CAUSE OF DEATH WAS RENAL AND HEART FAILURE. LAST DEVICE CHECK WAS (B)(6) 2010 AND EVERYTHING WAS FINE OTHER THAN RISING IMPEDANCES TO 1520 OHMS. THE PHYSICIAN PLANNED TO "PROACTIVELY REPLACE THE 6949 LEAD" DUE TO THE RISING IMPEDANCES. IT WAS ALSO REPORTED THE PATIENT HAD QUITE A BIT OF VT THAT HAD BEEN APPROPRIATELY TREATED - "NO PROBLEMS WITH THE LEAD OR THE DEVICE PERFORMANCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| D154AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD