BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD

    MDR report key: 2212575 · Received August 11, 2011

    Report

    Report Number
    1627487-2011-08033
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    THE PT RECEIVED SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT THE PT DID NOT FEEL STIMULATION AND SUFFERED FROM PAIN. THE AMPLITUDE DID NOT GET PAST PERCEPTION LEVEL AND THE LEAD CONTACTS DISPLAYED INVALID VALUES. X-RAY REVEALED A KINK IN THE LEAD AT THE LOCATION OF THE SWIFT-LOCK ANCHOR. THE LEAD WAS PLACED IN THE THORACIC AREA, AND NO STAIN RELIEFS WERE USED AT THE ANCHOR. THE PT WAS SCHEDULED TO BE REVISED. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3170829

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention SCS IPG: MODEL 3788| SCS LEAD ANCHOR: MODEL 1192| IMPLANT:| IMPLANT: