BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPENTA

    MDR report key: 3960198 · Received July 23, 2014

    Report

    Report Number
    1627487-2014-01480
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 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

    IT WAS REPORTED THE LEAD MIGRATED AND AS A RESULT, STIMULATION HAD DECREASED TO THE PAIN AREAS. F/U REVEALED SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2014 EXPLANTING AND REPLACING THE LEAD. EFFECTIVE STIMULATION WAS ACHIEVED POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429828 IPENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 4468733

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other SCS IPG: MODEL 3789| IMPLANT DATE: