BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3862844 · Received May 23, 2014

    Report

    Report Number
    1627487-2014-23329
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 28, 2014
    Manufacturer
    ST. JUDE MEDICAL ¿ NEUROMODULATION
    Product Code
    GZB
    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

    IT WAS REPORTED THE PT IS NOT RECEIVING EFFECTIVE STIMULATION POST-OPERATIVE. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. X-RAYS WERE TAKEN AND REVEALED THAT LEAD HAS MIGRATED OUT OF THE EPIDURAL SPACE. FOLLOW-UP INFO REVEALED THE PT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2014, WHERE THE LEAD WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309161 PENTA SCS LEAD GZB ST. JUDE MEDICAL ¿ NEUROMODULATION 3228 4319391

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other IMPLANT DATE:| SCS IPG, MODEL 3788,