BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELOX JT 53

    MDR report key: 1952052 · Received January 3, 2011

    Report

    Report Number
    1028232-2010-02879
    Event Type
    Injury
    Date Received
    January 3, 2011
    Report Date
    December 22, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR - THE PERFORMANCE OF THE LEADS UNDER COMPLAINTS WERE SCRUTINIZED. THE ANALYSIS OF BOTH THE SELOX JT AND THE PJN (B)(4) LEAD DEMONSTRATED AN ABRASION OF THE LEAD'S OUTER INSULATION. THIS INSULATION DAMAGE CAN BE CONSIDERED AS THE ROOT CAUSE FOR THE OBSERVED OVERSENSING ISSUES AS MENTIONED IN THE COMPLAINT DESCRIPTION. BASED ON THE CHARACTERISTICS, THE GEOMETRY AND THE LOCATION OF THESE DAMAGES, IT IS REASONABLE TO ASSUME THAT THE LEADS HAD BEEN SUBJECT TO EXCESSIVE AND CONTINUOUS MECHANICAL STRESS. THE INTERACTION BETWEEN THE LEADS SHOULD BE TAKEN INTO CONSIDERATION. THE INSULATION DAMAGE AT THE PROXIMAL PART OF THE SELOX JT LEAD RESULTED MOST LIKELY FROM THE EXPLANTATION PROCEDURE. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - INAPPROPRIATE PACING IMPEDANCES WERE REPORTED AND SUBCLAVIAN CRUSH WAS SUSPECTED. IMPLANT AND EXPLANT DATES WERE NOT REPORTED TO BIOTRONIK. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX JT 53 PACER LEAD NVZ BIOTRONIK SE & CO. KG 346368

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization