BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE EPI

    MDR report key: 1653213 · Received April 7, 2010

    Report

    Report Number
    2182208-2010-00162
    Event Type
    Malfunction
    Date Received
    April 7, 2010
    Date of Event
    November 13, 2009
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024/S2
    Removal / Correction Number
    ASKU
    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. EVALUATION SUMMARY: (B)(4): NO ANOMALIES FOUND; PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAS BEEN ANALYZED. BATTERY VOLTAGE - BATTERY DEPLETION INDICATED/ERI: TIME OF RRT IN SAVE TO DISK ON (B)(4) 2009, DEVICE RRT<=2.62 VOLT. DAILY BATTERY VOLTAGE TREND DATA SHOWS BAT=2.64 TO 2.62 VOLTS MINIMUM BETWEEN (B)(4) 2009 AND (B)(4) 2009. ONE - PATIENT ALERT FOR LOW BATTERY VOLTAGE BETWEEN (B)(4) 2009 02:15:04. IMPEDANCE - HIGH RESISTANCE/IMPEDANCE: TWO - PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(4) 2007 02:15:04 AND (B)(4) 2007 02:15:04. PROGRAMMER S2D DATA FOR FILE _357000 SHOWS LV PACING LEAD IMPEDANCE >2500 OHMS ON (B)(4) 2007 02:15:04 AND (B)(4) 2007 02:15:04. THE DEVICE WAS RETURNED AND ANALYZED. THE BATTERY DEPLETION WAS FOUND TO BE NORMAL AND MET EXPECTED LONGEVITY.

    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 LEAD 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): NO ANOMALIES FOUND; PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS REMOVED AND REPLACED DUE TO UNACCEPTABLE AND ELEVATED THRESHOLDS. IT WAS FURTHER REPORTED THAT THE DEVICE ONLY LASTED TWO YEARS. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS REMOVED AND REPLACED DUE TO UNACCEPTABLE AND ELEVATED THRESHOLDS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS REMOVED AND REPLACED DUE TO UNACCEPTABLE AND ELEVATED THRESHOLDS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE EPI IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4968 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 6931 IMPLANTABLE TACHY LEAD| 6931 IMPLANTABLE TACHY LEAD| 6931 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| C154DWK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| C154DWK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| C154DWK IMPLANTABLE PACEMAKER/CARDIO/DEFIB