BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 3993434 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09318
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 MEDICAL PRODUCTS: 407452 IMPLANTABLE PACING LEAD, (B)(6) 2005; 3889-28 INTERSTIM URINARY MGU LEAD, (B)(6) 2008; 3095-10 NEURO EXTENSION, (B)(6) 2008; 3023 INTERSTIM URINARY MGU IPG, (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD HIGH IMPEDANCE AND NO CAPTURE. THE RA 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
    471778 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 457445

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| R P1501DR IMPLANTABLE PULSE GENERATOR