BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELOX SR 53

    MDR report key: 3173914 · Received June 17, 2013

    Report

    Report Number
    1028232-2013-01705
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    April 5, 2011
    Report Date
    June 4, 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 FOUND DISSECTED. BOTH PARTS OF THE LEAD WERE RECEIVED. IT IS REASONABLE TO ASSUME THAT THE LEAD WAS DISSECTED IN THE COURSE OF THE LEAD EXPLANTATION. THE INSPECTION OF THE LEAD FRAGMENTS SHOWED, NEXT TO EXPLANT DAMAGES, NO DEVIATIONS WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE WERE RE-INVESTIGATED. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING PRODUCTION AND FINAL ACCEPTANCE TEST. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS LEAD BECAME DISLODGED AND WAS CAPPED ON (B)(6) 2011. THIS LEAD WAS EXPLANTED ON (B)(6) 2013 WHEN THE PATIENT WAS UPGRADED TO A CRT-D. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273691 SELOX SR 53 PACER LEAD NVN BIOTRONIK SE & CO. KG 343083

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization