BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUARTET

    MDR report key: 6175636 · Received December 15, 2016

    Report

    Report Number
    2938836-2016-17623
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    September 22, 2016
    Report Date
    October 26, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN DECIDED TO REPOSITION THE LEAD DUE TO HIGH THRESHOLDS. THE PHYSICIAN WAS UNABLE TO FLUSH THE LEAD OR ADVANCE ANY WIRE AFTER IT WAS EXPLANTED TO RE-IMPLANT AT DIFFERENT POSITION. THE LEAD WAS REPLACED. THE PATIENT DID NOT HAVE ANY SYMPTOMS PRIOR TO CASE AND WAS STABLE POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825949 QUARTET PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1458Q/86 A000002621

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention