BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 3063672 · Received April 17, 2013

    Report

    Report Number
    1028232-2013-01007
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    March 15, 2013
    Report Date
    April 8, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE DEVICE UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL, ELECTRICAL AND MECHANICAL INSPECTION. DURING THE VISUAL INSPECTION A BEND IN THE LEAD¿S DISTAL PART WAS NOTED AND THE LEAD¿S DISTAL PART WAS FOUND PARTLY PULLED OUT OF THE RING ELECTRODE. THESE DAMAGES REQUIRE THE PRESENCE OF MECHANICAL STRESS. TENSILE FORCES DURING SURGERY SHOULD BE TAKEN INTO CONSIDERATION. IN SUMMARY, A BEND IN THE LEAD¿S DISTAL PART WAS NOTED, CAUSING THE ISSUES DESCRIBED IN THE COMPLAINT DESCRIPTION. THERE WAS NO SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.

    Description of Event or Problem · 1

    THIS LEAD HAD DISLODGED A COUPLE OF TIMES SO THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE IT. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED. THE HOSPITAL RETAINED THE DEVICE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166204 SETROX S 53 PACER LEAD NVN BIOTRONIK SE & CO. KG 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization