BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPICARDIAL LEAD

    MDR report key: 2812564 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03815
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 27, 2012
    Report Date
    July 5, 2023
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE LV (LEFT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. LV PACING IMPEDANCE MEASURED HIGH ON (B)(6) 2015 AT 4047 OHMS.. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY:THE LEAD WAS NOT RETURNED FOR EVALUATION. HOWEVER, PERFORMANCE INFORMATION COLLECTED ON THE DEVICE WAS RECEIVED AND ANALYZED. THERE WAS A RECORDED PATIENT ALERT FOR OUT OF TOLERANCE SUB-THRESHOLD LEAD IMPEDANCE ON (B)(6) 2012. THE WEEKLY PACING LEAD TREND DATA SHOWED AN ABRUPT INCREASE FOR MINIMUM AND MAXIMUM LEFT VENTRICULAR (LV) LEAD PERMANENT PACING IMPEDANCE OF 703 TO 4047 OHMS PEAK BETWEEN (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT VENTRICULAR (LV) LEAD HAD HIGH IMPEDANCE. THE LEAD PROGRAMMING WAS ADJUSTED AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT FELT DIZZY, NAUSEOUS, SHORT OF BREATH, AND TIRED. HIGH LV THRESHOLDS WERE NOTED.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT THE LV LEAD HAD NO CAPTURE IN THE CONFIGURATION OF LV TIP TO LV RING. THE PATIENT WAS A PARTICIPANT IN THE (B)(4) STUDY.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED INTERMITTENT PAIN IN THEIR LEFT SHOULD BLADE. THE LEAD WAS ELECTRICALLY ABANDONED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED CARDIOMYOPATHY. THE PATIENT IS A PARTICIPANT IN THE POST APPROVAL CLINICAL SURVEILLANCE PRODUCT SURVEILLANCE REGISTRY. IT WAS ALSO REPORTED THAT THE LV LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE EPICARDIAL LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 4968

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5568 IMPLANTABLE PACING LEAD| 6725 IMPLANTABLE PACING LEAD ADAPTOR| 6947 IMPLANTABLE TACHY LEAD| 5568 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 6725 IMPLANTABLE PACING LEAD ADAPTOR