BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3052279 · Received April 4, 2013

    Report

    Report Number
    1627487-2013-01387
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-1388. IT WAS REPORTED THE PT IS NOT RECEIVING EFFECTIVE STIMULATION AND SHE IS EXPERIENCING SORENESS AT HER IPG SITE. THE PT REPORTED MULTIPLE SJM REPRESENTATIVES HAVE MET WITH HER FOR REPROGRAMMING, BUT THEY WERE NEVER ABLE TO GET EFFECTIVE STIMULATION COVERAGE. THE PT NEEDS STIMULATION IN BOTH LEGS BUT DURING PROGRAMMING SHE WOULD FEEL STIMULATION IN HER ABDOMEN. THE PT STATED SHE IS AFRAID TO USE OR CHARGE HER IPG AND IS CONSULTING WITH HER PHYSICIAN ON WHETHER TO HAVE HER SCS SYSTEM REVISED OR REMOVED. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139350 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3252464

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention