BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2051322 · Received April 7, 2011

    Report

    Report Number
    1627487-2011-01343
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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

    THE PT UNDERWENT A TRIAL PROCEDURE FOR A SCS SYSTEM, AND THE PT WAS IMPLANTED WITH TWO PERCUTANEOUS LEADS (FROM THE SAME LOT) ON (B)(6) 2011. IT WAS REPORTED THAT A DURAL TEAR OR PUNCTURE OCCURRED DURING THE PROCEDURE. THE PHYSICIAN DID NOT SPECIFY WHETHER THE EVENT INVOLVED A DURAL TEAR OR PUNCTURE, BUT HE STATED THAT CEREBROSPINAL FLUID LEAKAGE OCCURRED. IT WAS REPORTED THAT THE PT DEVELOPED A HEADACHE POSTOPERATIVE. THE LEADS WERE ALLEGEDLY NOT EXPLANTED. THE CURRENT STATUS OF THE PT'S SYMPTOMS IS UNK; NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3086 3260893

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R