BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT

    MDR report key: 1991840 · Received February 15, 2011

    Report

    Report Number
    2182208-2011-00159
    Event Type
    Death
    Date Received
    February 15, 2011
    Date of Event
    December 23, 2010
    Manufacturer
    MEDTRONIC, 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
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. PATIENT ALERT FOR RV PACE LEAD IMPEDANCE=1712 OHMS ON (B)(6) 2010 03:00:02. DAILY PACING LEAD IMPEDANCE DATA SHOWS AN ABRUPT SPIKE INCREASE FOR V.PACE=840 TO 1712 OHMS PEAK BETWEEN (B)(6) 2010 AND (B)(6) 2010, THEN V.PACE RETURNS TO THE BASELINE OF 856 OHMS.

    Additional Manufacturer Narrative · 1

    FURTHER REVIEW OF THE MANUFACTURER'S DATABASE ON (B)(4) 2011 INDICATED THE PATIENT WAS DECEASED AND THE DATE OF DEATH WAS (B)(6) 2011. THE CAUSE OF DEATH WAS REQUESTED AND IS NOT KNOWN. INFORMATION OBTAINED FROM THE CLINIC REPORTED THE PATIENT WAS FOUND DECEASED AT HOME AND NO AUTOPSY WAS PERFORMED. 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 ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ONE - PATIENT ALERT FOR RV PACE LEAD IMPEDANCE=1712 OHMS ON (B)(4)-2010 03:00:02. DAILY PACING LEAD IMPEDANCE DATA SHOWS AN ABRUPT SPIKE INCREASE FOR V.PACE=840 TO 1712 OHMS PEAK BETWEEN (B)(4)-2010, THEN V.PACE RETURNS TO THE BASELINE OF 856 OHMS. ONE - PATIENT ALERT FOR RV.PACE LEAD Z=1472 OHMS ON (B)(4)-2011 03:00:04. WEEKLY PACING LEAD IMPEDANCE DATA SHOW ABRUPT SPIKE INCREASES FOR MAX V.PACE=808 TO 1648 OHMS PEAK BETWEEN (B)(4)-2011 AND (B)(4)-2010.

    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 ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ONE PATIENT ALERT FOR RV PACE LEAD IMPEDANCE=1712 OHMS ON (B)(6) 2010 03:00:02. DAILY PACING LEAD IMPEDANCE DATA SHOWS AN ABRUPT SPIKE INCREASE FOR V.PACE=840 TO 1712 OHMS PEAK BETWEEN (B)(6) 2010 AND (B)(6) 2010, THEN V.PACE RETURNS TO THE BASELINE OF 856 OHMS. ONE PATIENT ALERT FOR RV PACE LEAD Z=1472 OHMS ON (B)(6) 2011 03:00:04. WEEKLY PACING LEAD IMPEDANCE DATA SHOW ABRUPT SPIKE INCREASES FOR MAX V.PACE=808 TO 1648 OHMS PEAK BETWEEN (B)(6) 2011 AND (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPEDANCE LEVEL ON THE LEAD WAS HIGH ON A SINGLE DAY. THE LEAD WILL BE MONITORED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPEDANCE LEVEL ON THE LEAD WAS HIGH ON A SINGLE DAY. THE LEAD WILL BE MONITORED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT SINCE THAT FIRST JUMP IN LEAD IMPEDANCE SEVERAL OTHER RISES HAVE BEEN NOTED. THE PATIENT IS BEING MONITORED MONTHLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPEDANCE LEVEL ON THE LEAD WAS HIGH ON A SINGLE DAY. THE LEAD WILL BE MONITORED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT SINCE THAT FIRST JUMP IN LEAD IMPEDANCE SEVERAL OTHER RISES HAVE BEEN NOTED. THE PATIENT IS BEING MONITORED MONTHLY. IT WAS FURTHER REPORTED THAT THE LEAD WAS OVERSENSING AND CONTINUED TO HAVE SPORADIC AND HIGH IMPEDANCES. THE POTENTIAL OF A LEAD FRACTURE WAS DISCUSSED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death| O (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB