BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYROX PX 60/15-BP

    MDR report key: 1841117 · Received September 17, 2010

    Report

    Report Number
    1028232-2010-01895
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    March 5, 2010
    Report Date
    August 17, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    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 MFG PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MFG 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 MFG.

    Description of Event or Problem · 1

    PER BIOTRONIK REP (B)(4), THIS PT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT. PRIOR TO THE ACCIDENT, THE PT WAS EVALUATED FOR SYNCOPY AND HIS PACEMAKER SYSTEM WAS FOUND TO BE FUNCTIONING APPROPRIATELY. POST ACCIDENT, THE VENTRICULAR LEAD WAS FOUND WITH EVIDENCE OF SUBCLAVIAN CRUSH AND LOSS OF VENTRICULAR FUNCTION. THE LEAD WAS CAPPED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYROX PX 60/15-BP PACER LEAD NVZ BIOTRONIK SE & CO. KG 130051

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization