BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD, 60 CM

    MDR report key: 2251298 · Received September 12, 2011

    Report

    Report Number
    1627487-2011-01923
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 16, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 HIS SCS TRIAL SYSTEM, INCLUDING TWO PERCUTANEOUS LEADS (FROM THE SAME LOT), ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT AWOKE IN THE MIDDLE OF THE NIGHT WITH THE BACK OF HIS SHIRT VERY WET NEAR THE SITE OF LEAD INSERTION. UPON GETTING OUT OF BED AND REMOVING HIS SHIRT, THE TAPE, TEGADERM AND LEADS FELL OFF/OUT OF HIS BACK. THE PATIENT ALSO STATED THAT HE HAD A HEADACHE. FOLLOW UP ON THE PATIENT FOUND THAT THE HEADACHE RESOLVED AND NO FURTHER PATIENT ISSUES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD, 60 CM SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3345982

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention