BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE 16-CM LENGTH PERCUTANEOUS LEAD

    MDR report key: 2160674 · Received July 7, 2011

    Report

    Report Number
    1627487-2011-03226
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 1 OF 2. REFERENCE MFR REPORT: 1627487-2011-03246. THE PT RECEIVED AN SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT THE PT COULD NOT INCREASE THE STIMULATION PAST 5 BARS. THE PT DID NOT FEEL THE STIMULATION ON HER RIGHT SIDE, ONLY HER LEFT SIDE. IT IS SUSPECTED ONE OF THE LEADS MIGRATED. THE PHYSICIAN HAS SCHEDULED A REVISION TO RESOLVE THE ISSUE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE 16-CM LENGTH PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3219025

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3788