BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3032058 · Received March 26, 2013

    Report

    Report Number
    1627487-2013-12393
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    November 11, 2008
    Report Date
    February 28, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 2 OF 2. REFERENCE MFR REPORT # 1627487-2013-12392. THE PT REC'D A LETTER REGARDING THE CHARGER SWAP PROGRAM AND REFUSED THE CHARGER SWAP. THE PT REPORTS ONLY USING THE SYSTEM FOR THE FIRST TWO WEEKS AFTER IMPLANT AS HE FOUND IT INEFFECTIVE AND POSSIBLE BOWEL/BLADDER ISSUES. THE SJM REP MET WITH THE PT, HOWEVER THE PT REFUSED REPROGRAMMING. THE PT WANTS THE SYSTEM EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124146 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 172085

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention