BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2850097 · Received November 26, 2012

    Report

    Report Number
    1627487-2012-11703
    Event Type
    Injury
    Date Received
    November 26, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    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 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 1 OF 2. REFERENCE MFR REPORT: 1627487-2012-11704. IT WAS REPORTED THE PATIENT HAD LOST STIMULATION ON ONE SIDE OF HER BODY, AND THE LEAD HAD NOT MIGRATED. THE PHYSICIAN OPTED THE REPLACE THE LEAD AND THE IPG. IT WAS REPORTED THE PATIENT RECEIVED EFFECTIVE STIMULATION POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3185468

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention