BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 45

    MDR report key: 3040761 · Received April 8, 2013

    Report

    Report Number
    1028232-2013-00923
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    February 15, 2013
    Report Date
    March 25, 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

    THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED INCLUDING A VISUAL AND AN ELECTRICAL ANALYSIS. THE ANALYSIS OF THE LEAD DEMONSTRATED A DAMAGED INSULATION AND A FRACTURED OUTER COIL AT A DISTANCE OF SOME 20.5 CM DISTAL TO THE IS-1 CONNECTOR PIN. IN THAT SECTION, THE LEAD BODY WAS FOUND SQUEEZED AND DEFORMED. BASED ON THE CHARACTERISTICS AS WELL AS THE LOCATION OF THE DAMAGE, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO EXCESSIVE MECHANICAL FORCES AS THE RESULT OF CLAVICULAR - FIRST RIB ENTRAPMENT. FURTHER DAMAGES OCCURRED MOST LIKELY DURING THE EXPLANT PROCEDURE. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS DEVICE WAS RETURNED WITH NO INFORMATION. A COMPETITOR WAS ABLE TO CONFIRM THIS PATIENT RECEIVED ONE OF THEIR SYSTEMS. THE FOLLOWING PHYSICIAN'S OFFICE HAS NO INFORMATION REGARDING THIS EXPLANT AS THE PATIENT HAS NOT BEEN SEEN SINCE 2010. THE REASON FOR REMOVAL IS UNKNOWN. THERE ARE NO KNOWN COMPLAINTS ASSOCIATED WITH THE FUNCTIONALITY OF THIS DEVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142991 SETROX S 45 PACER LEAD NVN BIOTRONIK SE & CO. KG 350973

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization