BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA LEAD KIT, 60CM LENGTH

    MDR report key: 1936268 · Received December 14, 2010

    Report

    Report Number
    1627487-2010-03915
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    SJM NEUROMODULATION DIV.
    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

    THE EVENT CANNOT BE CONFIRMED THROUGH PRODUCT ANALYSIS TESTING. SJM HAS LIMITED INFORMATION 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 2. SEE MFR REPORT # 1627487-2010-03917. THE PT RECEIVED HIS SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT THE SYSTEM WAS EXPLANTED ON (B)(6) 2010 DUE TO AN INFECTION. THE IPG AND LEAD WERE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA LEAD KIT, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW SJM NEUROMODULATION DIV. 3228 3138574

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention