BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3082327 · Received April 16, 2013

    Report

    Report Number
    1627487-2013-12491
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    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

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT NUMBER: 1627487-2013-12490. IT WAS REPORTED THE PT WAS RECEIVING PAIN COVERAGE, BUT IT WAS NOT AS EFFECTIVE AS THE PAIN PUMP PREVIOUSLY USED BY THE PT. THE PHYSICIAN EXPLANTED THE IPG AND LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162738 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3768683

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention