BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELOX JT 53

    MDR report key: 3091995 · Received May 3, 2013

    Report

    Report Number
    1028232-2013-01234
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    March 7, 2013
    Report Date
    April 22, 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 UNDER COMPLAINT WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE LEAD WAS SCRUTINIZED, INCLUDING A VISUAL, MECHANICAL AND ELECTRICAL INSPECTION. THE ANALYSIS REVEALED A RUBBED THROUGH INSULATION AT APPROX 46 CM AND 50.5 CM DISTAL TO THE IS-1 CONNECTOR PIN. BASED ON THE CHARACTERISTICS AS WELL AS THE LOCATION OF THE DAMAGES, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO EXCESSIVE MECHANICAL FORCES IN THE IMPLANTED STATE AS THE RESULT OF AN INTERACTION BETWEEN THE LEAD BODY AND A NEARBY LEAD. THE INTERACTION BETWEEN BOTH LEADS MIGHT HAVE LED TO THE DISLODGEMENT MENTIONED IN THE COMPLAINT DESCRIPTION. THE ANALYSIS DID NOT REVEAL ANY 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 WAS EXPLANTED AND REPLACED DUE TO DISLODGEMENT. 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
    193918 SELOX JT 53 PACER LEAD NVN BIOTRONIK SE & CO. KG 346368

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization