BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 2040972 · Received March 25, 2011

    Report

    Report Number
    1627487-2011-00405
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    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 SURGICAL LEAD FOR BACK AND LEG PAIN ON (B)(6) 2010. IT WAS REPORTED THAT SHE WAS EXPERIENCING LOWER ABDOMINAL PAIN. F/U ON THE PT FOUND THAT THE REPORTED DISCOMFORT IS SUBSIDING. NO ADD'L ISSUES WERE REPORTED. ACCORDING TO THE MFR'S REGISTRATION RECORDS, ALL COMPONENTS OF THE PT'S SCS SYSTEM REMAIN IMPLANTED.

    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 3136518

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention