BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2951469 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00122
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 26, 2012
    Report Date
    February 27, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 PRODUCTS 5076 IMPLANTABLE PACING LEAD (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. THERE WERE NO ANOMALIES FOUND. IT WAS VISUALLY NOTED THAT THERE WAS APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH SYNCOPE AND BECAME FEBRILE, AND FOUND THAT THE PATIENT HAD STAPH BACTEREMIA INFECTION. IT WAS NOTED BY THE PHYSICIAN THAT THE DEVICE POCKET APPEARED NORMAL AND THERE WAS NO VEGETATION ON THE LEAD. IT WAS ALSO NOTED THAT THE PATIENT HAD THE SAME INFECTION PREVIOUSLY, PRIOR TO THE DEVICE SYSTEM WAS IMPLANTED. THE LEADS AND DEVICE WERE REMOVED, AND ANTIBIOTIC TREATMENT PRESCRIBED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55662 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)