BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 2030929 · Received March 22, 2011

    Report

    Report Number
    1627487-2011-00376
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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 WAS IMPLANTED WITH A PERCUTANEOUS LEAD ON (B)(6) 2009. IT WAS REPORTED THAT DURING A RECENT REPROGRAMMING SESSION, SEVERAL OF THE PT'S LEAD CONTACTS EXHIBITED INVALID IMPEDANCE READINGS. A SUBSEQUENT X-RAY REVEALED A FRACTURE BETWEEN CONTACTS THREE AND FOUR OF THE DEVICE. SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE LEAD, AND EFFECTIVE STIMULATION WAS REPORTEDLY RECAPTURED FOR THE PT AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD KIT, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3186 2822523

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention