BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 2953549 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01201
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    December 7, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061/S012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT DATE UPDATED TO (B)(6) 2001.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS AND LIGHTHEADEDNESS. THE RIGHT VENTRICULAR (RV) LEAD DISPLAYED SOME PACED BEATS WITH LOSS OF CAPTURE AND HIGH THRESHOLD. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS AND LIGHTHEADEDNESS. THE RIGHT VENTRICULAR (RV) LEAD DISPLAYED SOME PACED BEATS WITH LOSS OF CAPTURE AND HIGH THRESHOLD. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57476 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4024

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R D284VRC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR