BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 2865020 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17611
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    October 30, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089/S015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. CONCOMITANT DEVICES: 5568 IMPLANTABLE PACING LEAD (B)(6) 1999. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BIPOLAR IMPEDANCE OF THE RIGHT VENTRICULAR (RV) LEAD WAS HIGH. THE LEAD WAS CAPPED AND REPLACED. 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 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5024M

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)