BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 1791330 · Received August 10, 2010

    Report

    Report Number
    2182208-2010-00431
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    February 23, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S15
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. PREVIOUS EXPERIENCE FROM A RETRO REVIEW FOR DEVICES STILL IN USE HAS BEEN INCORPORATED INTO THIS REPORT. EVALUATION SUMMARY; (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE DATA INDICATES THAT THE VENTRICULAR LEAD IMPEDANCE HAS INCREASED SINCE THE (B)(6) 2009 TIMEFRAME.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PREVIOUS EXPERIENCE FROM A RETRO REVIEW FOR DEVICES STILL IN USE HAS BEEN INCORPORATED INTO THIS REPORT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PREVIOUS EXPERIENCE FROM A RETRO REVIEW FOR DEVICES STILL IN USE HAS BEEN INCORPORATED INTO THIS REPORT. EVALUATION SUMMARY; (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE DATA INDICATES THAT THE VENTRICULAR LEAD IMPEDANCE HAS INCREASED SINCE THE SEPTEMBER 2009 TIMEFRAME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RV LEAD IMPEDANCE HAS BEEN INCREASING OVER THE PAST 9 MONTHS. SENSING AND THRESHOLDS HAVE BEEN STABLE. THE POLARITY WAS SWITCHED TO UNIPOLAR IN FEBRUARY. PREVIOUS EXPERIENCE ON THIS DEVICE INCLUDES AN INCREASE IN IMPEDANCE WITH A READING OF 1437 OHMS. IT WAS FURTHER REPORTED THAT THE LEAD EXHIBITED HIGH IMPEDANCES AND WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RV LEAD IMPEDANCE HAS BEEN INCREASING OVER THE PAST 9 MONTHS. SENSING AND THRESHOLDS HAVE BEEN STABLE. THE POLARITY WAS SWITCHED TO UNIPOLAR IN FEBRUARY. PREVIOUS EXPERIENCE ON THIS DEVICE INCLUDES AN INCREASE IN IMPEDANCE WITH A READING OF 1437 OHMS. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 5024M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR| 4058M IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR| 4058M IMPLANTABLE PACING LEAD| 4058M IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR