BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2955447 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01413
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    December 4, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 PRODUCT: 4024 IMPLANTABLE PACING LEAD 1998 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD HAD LOW IMPEDANCE. THE LEADS WERE REPROGRAMMED AND LATER CAPPED AND REPLACED AT THE TIME OF THE IMPLANTABLE PULSE GENERATOR (IPG) CHANGE DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59952 CAPSUREFIX DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 4068-52

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 7960IB