BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP 4024

    MDR report key: 2955164 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-00807
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. (B)(4).

    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 RIGHT VENTRICULAR (RV) LEAD IMPEDANCE WAS TRENDING DOWN WITH BIPOLAR IMPEDANCE LESS THAN UNIPOLAR IMPEDANCE. THERE WAS CONCERN ABOUT A POTENTIAL INSULATION BREACH. THE LEAD WAS REPROGRAMMED TO UNIPOLAR CONFIGURATION. THE LEAD WAS, SUBSEQUENTLY, CAPPED AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59662 CAPSURE SP 4024 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4024-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)