BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 3113301 · Received April 23, 2013

    Report

    Report Number
    1627487-2013-05583
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR. REPORT#: 1627487-2013-05582. ON 04/01/2013, THE PT UNDERWENT A PERMANENT IMPLANT PROCEDURE. INTRA-OP, HIGH IMPEDANCE WAS PRESENT. X-RAYS REVEALED THE LEAD WAS NOT FULLY INSERTED IN THE IPG HEADER. INVALID IMPEDANCE BECAME PRESENT AFTER THE LEAD WAS FULLY INSERTED IN THE IPG HEADER. A LEAD FRACTURE WAS SUSPECTED. AS A RESULT, THE LEAD WAS REPLACED. THE REPLACEMENT LEAD RESOLVED THE PT'S ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175377 UNKNOWN SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention