BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD, 60CM LENGTH

    MDR report key: 2133568 · Received June 16, 2011

    Report

    Report Number
    1627487-2011-00832
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 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

    DEVICE 2 OF 3. REFERENCE MFR REPORT #S: 1627487-2011-00831 AND 1627487-2011-00833. THE PT RECEIVED AN SCS SYSTEM INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS FROM DIFFERENT LOTS. IT WAS REPORTED THAT PT WAS FEELING STIMULATION IN HIS RIBS. EFFORTS TO RECAPTURE EFFECTIVE THERAPY COVERAGE VIA REPROGRAMMING WAS UNSUCCESSFUL. SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE PT'S LEADS. AT THAT TIME, THE IPG WAS ALSO REPLACED AS THE DEVICE HAD NOT BEEN CHARGED IN MONTHS AND NO COMMUNICATION COULD BE ESTABLISHED WITH IT USING EITHER THE PROGRAMMER OR CHARGING SYSTEM. EFFECTIVE STIMULATION WAS CAPTURED FOR THE PT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 2778448

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention SCS LEAD EXTENSION: MODEL 1194| IMPLANTED: