BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 3152088 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05544
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. THE FULL LEAD WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES. APPARENT EXPLANT DAMAGE WAS NOTED. (B)(4), IMPLANTABLE PULSE GENERATOR, (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD THRESHOLDS WOULD INCREASE WHILE THE PATIENT WAS SITTING, AND WOULD LOSE CAPTURE WHEN THE PATIENT WAS STANDING. THE LEAD WAS REMOVED 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
    252907 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4592-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Hospitalization| R 4092, IMPLANTABLE PACING LEAD