BEUDAMED
    FDA Adverse Event Other Summary report: N

    SELOX SR 53

    MDR report key: 739436 · Received July 21, 2006

    Report

    Report Number
    1028232-2006-00143
    Event Type
    Other
    Date Received
    July 21, 2006
    Report Date
    July 14, 2006
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    p950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IN 2006, STUDY SURVEILLANCE FORM RECEIVED FROM CLINICAL. PT WAS HOSPITALIZED DUE TO INFECTION. NO OTHER INFORMATION FROM PHYSICIAN, SYSTEM STILL IMPLANTED AND FOLLOW-UPS RECEIVED FROM CENTER. ON FIVE DAYS LATER, CONTACTED PHYSICIAN'S OFFICE. INFECTION WAS ON THE INCISION AREA, BUT NOT IN THE PACEMAKER POCKET. PATIENT WAS TREATED SUCCESSFULLY WITH IV ANTIBIOTICS AND RELEASED. DEVICE DID NOT NEED TO BE EXPLANTED AND REMAINS IMPLANTED. THIS IS PART OF A SYSTEM THAT INCLUDES: PHILOS II DR-T, MDR# 06-0142, SELOX SR 45, MDR# 06-0144. REVIEW OF CLINICAL STUDIES SHOWED THAT THIS DID NOT HAVE AN MDR REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX SR 53 BRADYCARDIA LEAD DTB BIOTRONIK GMBH AND CO. 343 083 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization