BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1697515 · Received May 25, 2010

    Report

    Report Number
    2649622-2010-05113
    Event Type
    Death
    Date Received
    May 25, 2010
    Date of Event
    May 9, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4) DISTAL CONDUCTOR FRACTURED. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B) (4) DISTAL CONDUCTOR FRACTURED. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B) (4) DISTAL CONDUCTOR FRACTURED. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER FOLLOWING THE PATIENT'S DEATH, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER FOLLOWING THE PATIENT'S DEATH, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. FOLLOW UP WITH THE CLINIC REPORTED THE CAUSE OF DEATH WAS HEART FAILURE COMPLICATIONS. THE DEVICE HAD BEEN TURNED OFF FOR PALLIATIVE CARE ON (B)(6)2010 PER THE FAMILY AND THE PATIENT WAS MADE A DO NOT RESUSCITATE. THE PATIENT HAD LAST BEEN SEEN IN THE CLINIC ON (B)(6)2010 AND HE WAS PACEMAKER DEPENDENT. DEATH CERTIFICATE LATER RECEIVED AND REPORTED CAUSE OF DEATH TO BE CONGESTIVE HEART FAILURE, CORONARY ARTERY DISEASE WITH SIGNIFICANT MEDICAL CONDITIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND SUSPECTED LUNG CANCER.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER FOLLOWING THE PATIENT'S DEATH, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. FOLLOW UP WITH THE CLINIC REPORTED THE CAUSE OF DEATH WAS HEART FAILURE COMPLICATIONS. THE DEVICE HAD BEEN TURNED OFF FOR PALLIATIVE CARE ON (B) (6) 2010 PER THE FAMILY AND THE PATIENT WAS MADE A DO NOT RESUSCITATE. THE PATIENT HAD LAST BEEN SEEN IN THE CLINID ON (B) (6) 2010 AND HE WAS PACEMAKER DEPENDENT.

    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 77 YR Death 5076 IMPLANTABLE PACING LEAD| 5071 IMPLANTABLE PACING LEAD| (B) (4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB