BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3192036 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-08234
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 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
    OK, 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: 1627487-2013-08233. THE PATIENT RECEIVED TWO LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT HAD NEITHER USED NOR RECHARGED HIS IPG (IMPLANTABLE PULSE GENERATOR) FOR AT LEAST A YEAR SINCE HE HAD INEFFECTIVE PAIN RELIEF. THE PATIENT REPORTED THE EXTERNAL DEVICES WERE NOT ABLE TO ESTABLISH COMMUNICATION WITH THE IPG AND THE SJM REPRESENTATIVE CONFIRMED IT IN THE FOLLOW-UP MEETING. THE PATIENT HAD BEEN SCHEDULED FOR AN IPG REPLACEMENT AT A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281810 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3190279

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other