BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3514048 · Received November 15, 2013

    Report

    Report Number
    1627487-2013-25012
    Event Type
    Injury
    Date Received
    November 15, 2013
    Date of Event
    October 22, 2013
    Report Date
    October 22, 2013
    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 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 PT IS NOT RECEIVING EFFECTIVE STIMULATION IN HER LOWER FOOT. THE PT UNDERWENT A TRIAL PROCEDURE ON (B)(6) 2013, TO TRY TO PROVIDE COVERAGE TO HER LOWER FOOT; HOWEVER, THE PROCEDURE WAS ABANDONED (REFERENCE MFR. 1627487-2013-0243150).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593986 PENTA GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3415711

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other SCS IPG: MODEL: 3716| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHORS: MODEL: 1194 (X2)