BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT

    MDR report key: 1663221 · Received April 21, 2010

    Report

    Report Number
    2649622-2010-01882
    Event Type
    Death
    Date Received
    April 21, 2010
    Date of Event
    March 31, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THERE WAS NO INDICATION THE DEATH WAS DEVICE RELATED; THE CAUSE OF DEATH HAS NOT BEEN DETERMINED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THERE WAS NO INDICATION THE DEATH WAS DEVICE RELATED; THE CAUSE OF DEATH HAS NOT BEEN DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THERE WAS NO INDICATION THE DEATH WAS DEVICE RELATED; THE CAUSE OF DEATH HAS NOT BEEN DETERMINED. EVALUATION SUMMARY (B) (4) NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THERE WAS NO INDICATION THE DEATH WAS DEVICE RELATED; THE CAUSE OF DEATH HAS NOT BEEN DETERMINED. EVALUATION SUMMARY (B) (4) NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S PHYSICIAN WAS ADVISED OF A SUDDEN INCREASE IN LEAD IMPEDANCES VIA A NOTIFICATION FROM THE CARELINK SYSTEM. A REVIEW OF THE TRANSMISSION REVEALED THE RV LEAD IMPEDANCES SUDDENLY INCREASED ON BOTH THE PACE/SENSE AND HIGH VOLTAGE COILS. THE CLINICIAN CONSULTED WITH THE MANUFACTURER'S TECHNICAL SERVICES AND WAS ADVISED TO BRING THE PATIENT IN FOR AN EXAMINATION. THE CLINICIAN ATTEMPTED TO REACH OUT TO THE PATIENT BY PHONE BUT WAS UNSUCCESSFUL. AT THIS TIME, THE CLINICIAN CONTACTED THE PATIENT'S SON. THE PATIENT'S SON ARRIVED AT THE PATIENT'S HOUSE A FEW HOURS LATER AND DISCOVERED THE PATIENT HAD EXPIRED. IF REMOVED, THE DEVICE AND LEAD WILL BE SENT TO THE MANUFACTURER FOR ANALYSIS. THERE IS NO ALLEGATION THE DEATH IS DEVICE-RELATED; HOWEVER, NO CAUSE OF DEATH HAS BEEN DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    (B) (4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S PHYSICIAN WAS ADVISED OF A SUDDEN INCREASE IN LEAD IMPEDANCES VIA A NOTIFICATION FROM THE CARELINK SYSTEM. TRANSMISSION REVIEW REVEALED RV LEAD IMPEDANCES SUDDENLY INCREASED ON BOTH THE PACE/SENSE AND HIGH VOLTAGE COILS. THE CLINICIAN CONSULTED WITH THE MANUFACTURER'S TECHNICAL SERVICES AND WAS ADVISED TO BRING THE PATIENT IN FOR AN EXAMINATION. THE CLINICIAN ATTEMPTED TO REACH OUT TO THE PATIENT BY PHONE BUT WAS UNSUCCESSFUL. AT THIS TIME, THE CLINICIAN CONTACTED THE PATIENT'S SON. THE PATIENT'S SON ARRIVED AT THE PATIENT'S HOUSE A FEW HOURS LATER AND DISCOVERED THE PATIENT HAD EXPIRED. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD LAST BEEN SEEN IN THE CLINIC (B) (6) 2009. THE PATIENT WAS NOT PACEMAKER DEPENDENT. THE PATIENT WAS FOUND DEAD IN HIS BED AT HOME. THE CAUSE OF DEATH IS UNKNOWN. THE PHYSICIAN THINKS "THE PATIENT DEATH (NOT RELATED TO THE DEVICE) CAUSED THE INCREASE IN THE IMPEDANCES."

    Description of Event or Problem · 1

    (B) (4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6943 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death (B) (4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB