BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE 60-CM LENGTH PERCUTANEOUS LEAD

    MDR report key: 2181430 · Received July 6, 2011

    Report

    Report Number
    1627487-2011-03212
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 7, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    THE PATIENT RECEIVED AN SCS SYSTEM ON (B)(6) 2008. IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED INTERMITTENT STIMULATION IN HIS LOWER BACK AND LEGS FOR THE PAST FOUR MONTHS. THE SJM REPRESENTATIVE WILL FOLLOW UP WITH THE PATIENT TO CHECK IMPEDANCES AND SPEAK WITH THE PHYSICIAN ABOUT TAKING AN X-RAY. IT WAS REPORTED THAT THE LEAD HAD AN INVALID CONTACT AND EFFECTIVE STIMULATION WAS RECAPTURED VIA REPROGRAMMING AROUND THE INVALID CONTACTS. NO FURTHER ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE 60-CM LENGTH PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 173576

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention SCS EXTENSION: MODEL 3382| IMPLANT:| SCS EXTENSION: MODEL 3342| IMPLANT:| SCS LEAD: MODEL 3146 (2)| IMPLANT: