BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 3071775 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05294
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    February 15, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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) IMPLANTABLE PACING LEAD (B)(6) 1995. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD WAS EXHIBITING NOISE. THE LEAD WAS REPROGRAMMED TO UNIPOLAR AND 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
    172828 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5524M45

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention (B)(4) IMPLANTABLE PULSE GENERATOR