BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2955595 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01496
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    December 5, 2022
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 PRODUCT: 5076 IMPLANTABLE PACING LEAD (B)(6) 2003. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS INTERMITTENT IMPEDANCE GREATER THAN 9,999 OHMS, NON-CAPTURE AND INTERMITTENT OVERSENSING ON THE ATRIAL LEAD. DURING REVISION OF THE LEAD, THE PHYSICIAN FELT THE SETSCREW ON THE IMPLANTABLE PULSE GENERATOR (IPG) WAS ABLE TO BE WIGGLED SIDEWAYS EVEN WHEN TIGHTENED DOWN. THE LEAD TESTED WITH NORMAL VALUES THROUGH THE ANALYZER. THE DEVICE WAS EXPLANTED AND A NEW IPG IMPLANTED. 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
    59794 CAPSUREFIX NOVUS PERMANENT PACEMAKER ELECTRODE DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Male Hospitalization| R ADDRL1 IMPLANTABLE PULSE GENERATOR| ADDRL1 IMPLANTABLE PULSE GENERATOR