BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2091616 · Received April 28, 2011

    Report

    Report Number
    1627487-2011-01439
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 27, 2011
    Report Date
    March 31, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    GZB
    PMA / PMN Number
    K960728
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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

    DEVICE 2 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2011-01438. THE PATIENT RECEIVED HIS SCS SYSTEM, INCLUDING TWO PERCUTANEOUS LEADS, ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT FELL AND SUBSEQUENTLY LOST STIMULATION IN HIS LOW BACK. HE STATED THAT HE ONLY FELT STIMULATION IN HIS LEGS. AN X-RAY REVEALED THAT THE LEADS HAD MIGRATED. THE PHYSICIAN REVISED THE LEADS ON (B)(6) 2011, AND THE PATIENT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION DIVISION 3186 3240653

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention