BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 4113007 · Received September 17, 2014

    Report

    Report Number
    1627487-2014-20225
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    July 26, 2014
    Report Date
    August 27, 2014
    Manufacturer
    ST JUDE MED - 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 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#: 1627487-2014-20234. IT WAS REPORTED THE PT EXPERIENCED OVER STIMULATION UPON TWISTING TO HER SIDE. X-RAYS SHOWED THE IPG HEADER WAS DOWN BUT X-RAYS FOR ORIGINAL PLACEMENT OF IPG WAS UNAVAILABLE TO COMPARE. ALSO, THE PT HAS EXPERIENCED MULTIPLE FALLS WITH INCREASING WEAKNESS IN HER LEFT LEG. SUBSEQUENTLY, THE SCS SYS WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574465 PENTA SCS LEAD GZB ST JUDE MED - NEUROMODULATION 3228 3345990

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other