BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1072567 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03983
    Event Type
    Death
    Date Received
    July 10, 2008
    Date of Event
    May 12, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    Z-0067-007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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; DISTAL SEGMENT RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    THIS EVENT INVOLVES A LEGAL CASE IN PROGRESS OR POTENTIAL LITIGATION. THE PROPRIETARY NATURE OF THE EVENT MAY AFFECT FOLLOW UP EFFORTS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. OUR RECORDS INDICATE THE PATIENT EXPIRED MORE THAN ONE YEAR AGO. WE HAVE NO INFORMATION TO SUGGEST THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN RESEARCHED BUT HAS NOT BEEN RECEIVED. EVALUATION SUMMARY: DISTAL CONDUCTOR FRACTURED; DISTAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    NO CAPTURE, HIGH IMPEDANCE, AND OVERSENSING REPORTED. LEAD EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS RESULT OF THIS EVENT. ATTORNEY LATER ALLEGES PATIENT SUFFERED PHYSICAL AND OTHER INJURY AS A RESULT OF RECALLED LEAD. FURTHER ALLEGED 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 SPRINT FIDELIS LEAD." ATTORNEY ALSO ALLEGES AS RESULT OF LEAD, PATIENT "SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH" AND PATIENT "DIED AS A DIRECT AND PROXIMATE RESULT OF DEFECTS" IN THE LEAD REVIEW OF MANUFACTURER'S DATABASE VERIFIED PATIENT DEATH AND ALSO THAT PATIENT DID NOT HAVE A SPRINT FIDELIS LEAD MODEL IMPLANTED AT TIME OF DEATH. NO ALLEGATION FROM HEALTH CARE PROFESSIONAL DEATH DEVICE RELATED. CAUSE OF DEATH RESEARCHED AND NOT RECEIVED.

    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 67 YR Death| R 5076 IMPLANTABLE PACING LEAD| 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4193 IMPLANTABLE PACING LEAD