BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3052284 · Received April 4, 2013

    Report

    Report Number
    1627487-2013-15455
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 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 EXPERIENCING INADEQUATE STIMULATION. THE PT IS RECEIVING BILATERAL LEG STIMULATION AND ONLY WANTS UNILATERAL. THE PT STATED STIMULATION IN ONE LEG IS SO STRONG THAT SHE CANNOT BALANCE AND THEN SHE IS EXPERIENCING RIB STIMULATION. REPROGRAMMING EFFORTS HAVE BEEN UNSUCCESSFUL. THE PHYSICIAN ORDERED A CT SCAN AND INDICATED SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137792 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3847919

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL: 3788