BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SITUS OTW

    MDR report key: 3022726 · Received March 22, 2013

    Report

    Report Number
    1000165971-2013-00168
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 19, 2013
    Manufacturer
    SORIN CRM
    Product Code
    NIK
    PMA / PMN Number
    P060027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2013. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT DURING A CRT-D REPLACEMENT PROCEDURE (SORIN CRT-D MODEL PARADYM SONR 8770, S/N (B)(4)), THE SUBJECT LEAD DISLODGED TO THE ATRIAL CHAMBER, SO RE-PROGRAMMING OF THE REPLACEMENT DEVICE EXCLUDED PACING THERAPY RELATIVE TO IT. DUE TO COMPLICATIONS RELATIVE TO THE DEFIBRILLATION LEAD (SORIN BRAND ISOLINE 2CR6, SN: (B)(4), MDR: 1000165971-2013-00167), ANOTHER REINTERVENTION WAS PERFORMED, AND THE SUBJECT LEAD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119459 SITUS OTW NIK SORIN CRM SITUS OTW UW28D 2294

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention