BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2091631 · Received April 28, 2011

    Report

    Report Number
    1627487-2011-01456
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    GZB
    PMA / PMN Number
    K960728
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: 1627487-2011-01455. THE PATIENT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT HAD LOST A LOT OF WEIGHT AND COMPLAINED OF PAIN AT HER IPG POCKET SITE. THE PHYSICIAN REVISED THE PATIENT'S IPG POCKET ON (B)(6) 2011. IT WAS REPORTED THAT APPROXIMATELY ONE HOUR AFTER POSTOPERATIVE PROGRAMMING, THE PATIENT STATED THAT SHE COULD NO LONGER TURN HER STIMULATION UP TO PERCEPTION. DIAGNOSTIC TESTS REVEALED HIGH IMPEDANCE MEASUREMENTS ON SEVERAL LEAD CONTACTS. A FEW DAYS LATER, THE PATIENT REPORTED, SHE WAS UNABLE TO TURN HER STIMULATION UP TO PERCEPTION AGAIN. DIAGNOSTIC TESTS REVEALED HIGH IMPEDANCE; HOWEVER, DIFFERENT LEAD CONTACTS WERE EXHIBITING THE HIGH READINGS. THE PATIENT WAS ALLEGEDLY REPROGRAMMED AND ACHIEVED ADEQUATE STIMULATION. 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 3163464

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention