BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL EXTENSION

    MDR report key: 3931861 · Received June 20, 2014

    Report

    Report Number
    1627487-2014-02449
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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: 1627487-2014-02448. THE PT RECEIVED TWO SCS EXTENSIONS FROM THE SAME LOT NUMBER. IT WAS REPORTED THE PT IS NOT RECEIVING EFFECTIVE STIMULATION FROM HIS SCS SYSTEM. A SJM REP MET WITH THE PT BUT REPROGRAMMING DID NOT RESOLVE THE ISSUE. TWO OF THE PT'S LEADS HAVE MULTIPLE CONTACTS WITH LOW IMPEDANCE. X-RAYS TAKEN INDICATED A POSSIBLE LEAD PULL AT THE IPG HEADER. SURGICAL INTERVENTION MAY BE UNDERTAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364229 DUAL EXTENSION SCS EXTENSION GZB ST. JUDE MEDICAL - NEUROMODULATION 3341 4361455

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other IMPLANT DATE:| SCS LEAD: MODEL 3146 (X2)| SCS LEAD: MODEL 3163 (X2)| IMPLANT DATE: