BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1039676 · Received May 9, 2008

    Report

    Report Number
    2649622-2008-03169
    Event Type
    Death
    Date Received
    May 9, 2008
    Date of Event
    March 25, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. EVALUATION SUMMARY: DISTAL CONDUCTOR FRACTURED; FULL LEAD IN SEGMENTS RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED AN ALLEGATION FROM AN ATTORNEY INDICATED THE PATIENT IS DECEASED AND FURTHER INDICATED THAT THE LEAD HAD EXHIBITED A FRACTURE AND/OR WAS EXPLANTED. 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. THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. EVALUATION SUMMARY: (B)(4) DISTAL CONDUCTOR FRACTURED; FULL LEAD IN SEGMENTS RETURNED AND ANALYZED.

    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 SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. EVALUATION SUMMARY: DISTAL CONDUCTOR FRACTURED; FULL LEAD IN SEGMENTS RETURNED AND ANALYZED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAD FRACTURE, THAT PART OF THE CONDUCTOR CAME OUT OF THE LEAD BODY WHEN CUT DURING EXPLANT PROCEDURE, AND THAT THE HELIX WOULD NOT RETRACT USING THE ROTATION TOOL BUT ONLY WHEN THERE WAS CONSTANT PULLING PRESSURE ON THE LEAD. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ALLEGING THE PATIENT "SUFFERED PHYSICAL AND OTHER INJURY", AND THAT 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]". IT ALSO ALLEGED THAT THE PATIENT "SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH, ECONOMIC LOSSES AND OTHER DAMAGES. [PATIENT] HAS FURTHER SUFFERED PHYSICAL INJURIES AND VARIOUS PHYSICAL MANIFESTATIONS OF EMOTIONAL DISTRESS".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAD FRACTURE, THAT PART OF THE CONDUCTOR CAME OUT OF THE LEAD BODY WHEN CUT DURING EXPLANT PROCEDURE, AND THAT THE HELIX WOULD NOT RETRACT USING THE ROTATION TOOL BUT ONLY WHEN THERE WAS CONSTANT PULLING PRESSURE ON THE LEAD. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED. ADDITIONAL INFORMATION WAS RECEIVED IN A LAWSUIT ALLEGING THE PATIENT "SUFFERED PHYSICAL AND OTHER INJURY", AND THAT 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]". IT ALSO ALLEGED THAT THE PATIENT "SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH, ECONOMIC LOSSES AND OTHER DAMAGES. [PATIENT] HAS FURTHER SUFFERED PHYSICAL INJURIES AND VARIOUS PHYSICAL MANIFESTATIONS OF EMOTIONAL DISTRESS".

    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 51 YR Death| H| L| O| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| D154VRC IMPLANTABLE PACEMAKER/CARDIO/DEFIB