BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD, 60CM LENGTH

    MDR report key: 2113717 · Received June 2, 2011

    Report

    Report Number
    1627487-2011-00756
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    DEVICE 1 OF 3. REFERENCE MFR REPORT #S 1627487-2011-00757 AND 1627487-2011-00758. THE PT RECEIVED AN SCS SYSTEM INCLUDING THREE PERCUTANEOUS LEADS ON (B)(6) 2011. IT WAS REPORTED THAT THE PT LOST STIMULATION AND WAS UNABLE TO INCREASE THE AMPLITUDE FOR HER THERAPY. A DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE MEASUREMENTS ON SEVERAL LEAD CONTACTS; HOWEVER, NO VISIBLE ANOMALIES COULD BE DETECTED VIA X-RAY. SURGICAL INTERVENTION WILL BE UNDERTAKEN AT A LATER DATE TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 2870917

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention IMPLANTED:| SCS LEACH ANCHOR: MODEL: 1192| SCS IPG: MODEL: 3788| IMPLANTED:| SCS LEAD EXTENSION: MODEL: 3341| IMPLANTED: