BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2058165 · Received April 14, 2011

    Report

    Report Number
    2649622-2011-07181
    Event Type
    Death
    Date Received
    April 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S030
    Removal / Correction Number
    Z-0069-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AN ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH A LEAD WIRE SYSTEM, AND "SUFFERED PHYSICAL AND OTHER INJURY AS A RESULT OF THE RECALLED LEAD". THE PATIENT "EXPERIENCED INAPPROPRIATE AND/OR EXCESSIVE SHOCKING, FRACTURE OR OTHER INJURY REQUIRING MEDICAL INTERVENTION INCLUDING BUT NOT LIMITED TO SURGERY, REMOVAL AND/OR REPLACEMENT OF THE DEFECTIVE" LEAD. THE PATIENT "HAS SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND /OR DEATH, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH, ECONOMIC LOSSES AND OTHER DAMAGES." FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT IS DECEASED AND DIED APPROXIMATELY TWENTY FIVE MONTHS POST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6948 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5554 IMPLANTABLE PACING LEAD