BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 3193457 · Received June 27, 2013

    Report

    Report Number
    1028232-2013-01822
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 17, 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. THE VISUAL INSPECTION DEMONSTRATED A DEFORMED FIXATION HELIX AND THE DISTAL PART OF THE LEAD PULLED OUT FROM THE RING ELECTRODE. THE ADHESIVE RESIDUALS ON THE JOINING SURFACE OF LEAD TIP AND THE LEAD BODY WERE ANALYSED. THE ANALYSIS REVEALED NO INDICATION OF A MATERIAL OR A MANUFACTURING PROBLEM. DAMAGES SUCH AS THOSE REQUIRE THE PRESENCE OF MECHANICAL STRESS. MECHANICAL STRESS DURING SURGERY SHOULD BE TAKEN INTO CONSIDERATION. DURING FURTHER ANALYSIS, NO OTHER DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS LEAD BECAME DISLODGED WHILE THE PHYSICIAN WAS EXPLANTING THE RV LEAD. THE PHYSICIAN CHOSE TO REPLACE THIS LEAD WITH AN (B)(4) DEVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291665 SETROX S 53 PACER LEAD NVN BIOTRONIK SE & CO. KG 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization