BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3993942 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09049
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 PRODUCTS: ADDRL1 IPG IMPLANTED: (B)(6) 2014; 8578 NEURO ACCESSORY IMPLANTED: (B)(6) 2012; 8637-40 NEURO PUMP IMPLANTED: (B)(6) 2012; 37713 PAIN STIM IPG IMPLANTED: (B)(6) 2012; 3708140 NEURO EXTENSION IMPLANTED: (B)(6) 2011; 3778-45 PAIN STIM LEAD IMPLANTED: (B)(6) 2011; 3788-45 PAIN STIM LEAD IMPLANTED: (B)(6) 2011; 8731 CATHETER IMPLANTED: (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT THRESHOLD WAS HIGH DUE TO THE DEVICE ALGORITHM BUT MANUAL THRESHOLDS WERE LOWER. A THRESHOLD VALUE WAS NOT OBSERVED ON THE TREND AND THE PATIENT WAS NOTED TO HAVE FREQUENT PREMATURE VENTRICULAR CONTRACTIONS. REPROGRAMMING WAS PERFORMED AT A SUBSEQUENT OFFICE VISIT, AND THE LEAD 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
    468925 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Required Intervention 5076-45 LEAD