BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3850705 · Received May 21, 2014

    Report

    Report Number
    1627487-2014-10113
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 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

    THE PATIENT WAS UNDERGOING SURGICAL INTERVENTION TO REPLACE HER ENTIRE SCS SYSTEM (REFERENCE MFR REPORTS: 1627487-2014-02208, 02209 AND 02210). IT WAS REPORTED DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY POSITIONING THE LEAD AT MIDLINE DUE TO THE PATIENT'S ANATOMY. POSTOPERATIVE PROGRAMMING WAS ABLE TO PROVIDE BILATERAL COVERAGE; HOWEVER, STIMULATION IS STRONGER ON THE RIGHT SIDE. REPROGRAMMING WILL BE ATTEMPTED AT A LATER DATE ONCE THE PATIENT'S POST-OPERATIVE PAIN SUBSIDES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303593 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 4468705

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other IMPLANT:| SCS IPG: MODEL 3688