BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 2230080 · Received August 31, 2011

    Report

    Report Number
    2182208-2011-02023
    Event Type
    Injury
    Date Received
    August 31, 2011
    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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCES AFTER IMPLANT WERE GREATER THAN 9999 OHMS. THE IMPEDANCE MEASUREMENTS HAVE SINCE STABILIZED TO READINGS OF 300-400 OHMS. IT WAS ALSO REPORTED THAT THERE HAS BEEN AN INCREASE IN THRESHOLDS OVER THE LAST YEAR. THE DEVICE HAS HAD TO BE REPROGRAMMED TO MAXIMUM OUTPUTS ON THE RV LEAD FOR SAFETY MARGIN BUT THE PATIENT PACES LESS THAN ONE PERCENT IN THE VENTRICLE. THE LEAD REMAINS 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 EPI IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4968 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention 4968 IMPLANTABLE PACING LEAD| ADDRS1 IMPLANTABLE PULSE GENERATOR