BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTA

    MDR report key: 3151479 · Received June 3, 2013

    Report

    Report Number
    1627487-2013-05772
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 HAS BEEN UNABLE TO RECEIVE ADEQUATE COVERAGE. REPROGRAMMING WAS UNSUCCESSFUL. THE PT WILL UNDERGO X-RAYS FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243668 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3763707

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention SCS ANCHOR: MODEL 1192| SCS IPG: MODEL 3716| IMPLANT:| IMPLANT: