BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE EXTENSION

    MDR report key: 3900130 · Received May 28, 2014

    Report

    Report Number
    1627487-2014-02361
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    ST. JUDE MEDICAL ¿ NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    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 PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT #1627487-2014-02362. IT WAS REPORTED THE PT HAD A REVISION SURGERY ON (B)(6) 2014 TO REPLACE A PREVIOUSLY EXPLANTED IPG (REF. MEDWATCH # 1627487-2014-02114) AND REVISE THE PT'S EXTENSION THAT WAS SEEN "COMING OUT OF HER INCISION SITE." PT'S EXTENSION WAS REMOVED AND REPLACED. REPORTED ISSUE WAS DETERMINED TO BE RESOLVED POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314781 SINGLE EXTENSION SCS EXTENSION GZB ST. JUDE MEDICAL ¿ NEUROMODULATION 3383 3486373

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other SCS LEAD, MODEL 3224| SCS IPG, MODEL 3788 (X2)| IMPLANT DATE:| SCS LEAD, MODEL 3228| IMPLANT DATE:| IMPLANT DATE: