BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2100784 · Received May 19, 2011

    Report

    Report Number
    1627487-2011-02621
    Event Type
    Injury
    Date Received
    May 19, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    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 HER SCS SYSTEM, INCLUDING TWO PERCUTANEOUS LEADS (OF THE SAME LOT), ON (B)(6) 2011. DURING THE IMPLANT PROCEDURE, A DURAL PUNCTURE OCCURRED. THE PUNCTURE WAS RESOLVED WITH A BLOOD PATCH. POSTOPERATIVE, THE PATIENT REPORTED A HEADACHE AND WEAKNESS IN HER RIGHT ANKLE. AS A RESULT, THE PHYSICIAN EXPLANTED THE SCS SYSTEM LATER THAT SAME DAY. IT IS UNKNOWN IF THE EPIDURAL SPACE WAS ASSESSED PREOPERATIVE. THE EXPLANTED PRODUCT WAS DISCARDED BY THE FACILITY. A POST-OPERATIVE MRI WAS PERFORMED; HOWEVER, NO ABNORMALITIES WERE FOUND. FOLLOW UP ON THE PATIENT FOUND THAT SHE IS STILL EXPERIENCING SOME WEAKNESS IN HER RIGHT ANKLE BUT OVERALL IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3240575

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization| R| S SCS IPG: MODEL 3788| IMPLANT: