BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP

    MDR report key: 3993618 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09216
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. PRODUCTS: A2DR01 IMPLANTABLE PULSE GENERATOR (IPG) IMPLANTED: 2014 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS CROSS TALK FROM THE RIGHT ATRIAL (RA) LEAD RESULTING IN RIGHT VENTRICULAR (RV) LEAD OVERSENSING WHEN CONNECTED TO THE PACING ANALYZER DURING THE DEVICE REPLACEMENT PROCEDURE. DISCONNECTING THE RA LEAD FROM THE ANALYZER RESULTED IN NO VENTRICULAR OVERSENSING AND NORMAL PACING AND TELEMETRY. THE REPLACEMENT DEVICE WAS IMPLANTED WITHOUT ISSUE AND THE RV 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
    468341 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5024

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR Hospitalization| R 5524 IMPLANTABLE PACING LEAD