BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2021030 · Received March 16, 2011

    Report

    Report Number
    2649622-2011-03936
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    January 22, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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. EVALUATION SUMMARY: (B)(4) THE LEAD WAS RETURNED AND ANALYSIS UNKNOWN/NOT ANALYZED. ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. THE LEAD IS PART OF THE ADVISORY FOR THIS MODEL. APPROXIMATELY ONE YEAR AFTER THE SECOND ATTORNEY ALLEGATION, INFORMATION WAS RECEIVED FROM A THIRD ATTORNEY ALLEGING THE PATIENT IS DECEASED AND FURTHER INDICATED THAT THE LEAD HAD EXHIBITED A FRACTURE AND/OR WAS EXPLANTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A COMPETITOR THAT THE PATIENT RECEIVED SHOCKS FROM THE RIGHT VENTRICULAR LEAD. ADDITIONAL INFORMATION WAS RECEIVED FROM AN ATTORNEY ALLEGING THE PATIENT RECEIVED REPEATED SHOCKS FROM THE FRACTURED LEAD. PATIENT PRESENTED TO THE EMERGENCY ROOM AND WAS INFORMED THE LEAD FRACTURED AND RECEIVED SHOCKS AS A RESULT OF THE LEAD FAILURE. THE LEAD WAS CAPPED AND REPLACED. APPROXIMATELY ONE YEAR AFTER THE FIRST ATTORNEY ALLEGATION, A SECOND ATTORNEY WAS ALLEGING THE PATIENT "SUFFERED PHYSICAL AND OTHER INJURY AS A RESULT OF THE RECALLED LEAD" AND "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. PATIENT HAS "SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH".

    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 64 YR Death 4470 COMPETITOR IMPLANTABLE PACING LEAD| 4543 COMPETITOR IMPLANTABLE PACING LEAD| H210 COMPETITOR IMPLANTABLE PACEMAKER/CARDIO/DEFIB