BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SETROX S 45

    MDR report key: 2080020 · Received April 5, 2011

    Report

    Report Number
    1028232-2011-00786
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    August 26, 2010
    Report Date
    August 31, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE ANALYSIS DEMONSTRATED THAT THE INTEGRITY OF THE LEAD WAS COMPROMISED DUE TO ABRASION OF THE LEAD'S INSULATION. IN ADDITION, THE ANALYSIS REVEALED A CONDUCTOR FRACTURE CLOSE TO THE LEAD TIP. BASED ON THE CHARACTERISTICS, THE GEOMETRY AND THE LOCATION OF THESE DAMAGES, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO EXCESSIVE AND CONTINUOUS MECHANICAL STRESS IN THE IMPLANTED STATE. THE INTERACTION WITH THE TRICUSPID VALVE SHOULD BE TAKEN INTO CONSIDERATION. DIAGNOSTIC IMAGES CLARIFYING THIS ASSUMPTION WERE NOT AVAILABLE FOR ANALYSIS. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MFG PROBLEM.

    Description of Event or Problem · 1

    AN EGM SHOWED NOISE ON THIS LEAD WHILE UPGRADING THE PT TO AN ICD. THE PHYSICIAN THOUGHT THE LEAD MIGHT HAVE BEEN FRACTURED. THERE WAS NO SIGN OF NOISE ON THE EGMS AND FOLLOW-UPS WITH THE PREVIOUS DEVICE, SO THE ISSUE IS BELIEVED TO HAVE OCCURRED DURING THE UPGRADE. THERE ARE NO ADVERSE EVENTS REPORTED FOR THIS PT. (B)(6). ON (B)(6) 2011 - BASED ON THE ANALYSIS FINDINGS OF LEAD FRACTURE, THIS EVENT IS NOW CONSIDERED A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 45 PACER LEAD NVZ BIOTRONIK SE & CO. KG 350973

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization