BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3133641 · Received May 20, 2013

    Report

    Report Number
    1627487-2013-15664
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ST. JUDE MEDICAL, NEUROMODULATION
    Product Code
    LGW
    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 PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED CRAMPING IN HIS STOMACH AND RIBS WHEN HE WOULD CHANGE POSITION. THE PATIENT TURNED STIMULATION OFF BUT THE ISSUE PERSISTED. PATIENT STATED HE WENT TO A MEDICAL CLINIC AND RECEIVED A STEROID INJECTION AND MUSCLE RELAXERS WHICH EASED THE CRAMPING. PATIENT FURTHER STATED HIS PHYSICIAN ORDERED A CT SCAN BECAUSE HE THINKS HE HAS A PINCHED NERVE. THE SJM REPRESENTATIVE MET WITH THE PATIENT ON (B)(6) 2013 AND PATIENT STATED HE IS NO LONGER CRAMPING. DIAGNOSTICS DID NOT REVEAL ANY IMPEDANCE ISSUES. PATIENT WAS REPROGRAMMED, EFFECTIVE STIMULATION WAS ACHIEVED AND PATIENT IS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223296 PENTA SCS LEAD LGW ST. JUDE MEDICAL, NEUROMODULATION 3228 3523723

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention SCS IPG: MODEL 3716| IMPLANT DATE: