BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 2080613 · Received April 25, 2011

    Report

    Report Number
    1627487-2011-00566
    Event Type
    Injury
    Date Received
    April 25, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 11, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    DEVICE 2 OF 4. REFERENCE MFR REPORT #S 1627487-2011-00555, 1627487-2011-00567 AND 1627487-2011-00568. THE PT RECEIVED AN SCS SYSTEM INCLUDING AN IPG, A SURGICAL LEAD AND TWO LEAD ANCHORS ON (B)(6) 2010. IT WAS REPORTED THAT HE WAS EXPERIENCING UNCOMFORTABLE STOMACH PAIN THAT INTERFERED WITH HIS STIMULATION. THE REPORTED DISCOMFORT WAS SAID TO BE PRESENT WHEN THE STIMULATION WAS NOT IN USE. THE PHYSICIAN ATTRIBUTED THE MAJORITY OF THE PT'S PAIN TO A POSSIBLE CLIPPED NERVE. EFFORTS TO RECTIFY THIS MATTER VIA PROGRAMMING PROVED UNSUCCESSFUL. AT THE PT'S REQUEST, HIS SCS SYSTEM WAS REMOVED. FOLLOW-UP ON THIS ISSUE FOUND THAT THE REPORTED PAIN STILL EXISTS, AND THE PT FEELS MARGINALLY BETTER SINCE THE REMOVAL OF HIS SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA 3MM LEAD, 60 CM SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3228 3168012

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention