BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE EXTENSION

    MDR report key: 3231425 · Received July 12, 2013

    Report

    Report Number
    1627487-2013-00406
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    April 12, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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#: 1627487-2013-00393. THE PT (B)(6) WAS IMPLANTED WITH TWO EXTENSIONS FROM DIFFERENT LOTS. IT WAS REPORTED THE PT EXPERIENCED A LOSS OF STIMULATION. A DIAGNOSTIC TEST REVEALED HIGH IMPEDANCE MEASUREMENTS FOR SEVERAL LEAD CONTACTS. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2013 TO EXPLANT AND REPLACE THE PT'S EXTENSION. THERAPY WAS RECAPTURED FOR THE PT FOLLOWING THE PROCEDURE. SINCE IT IS UNK WHICH OF THE PT'S EXTENSIONS WERE EXPLANTED, BOTH LOTS ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323678 SINGLE EXTENSION SCS EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3383 3773351

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other SCS IPG: MODEL 3788| SCS LEADS: MODEL 3189 X 2| IMPLANT DATE:| IMPLANT DATE: