BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2940669 · Received January 30, 2013

    Report

    Report Number
    1627487-2013-13154
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 8, 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 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 3 OF 3. REFERENCE MFR. REPORT: 1627487-2013-13152 AND 1627487-2013-13153. THE PT HAS TWO EXTENSIONS FROM THE SAME LOT NUMBER. IT WAS REPORTED THE PT WAS ADMITTED TO THE HOSPITAL DUE TO AN INFECTION AT HER OCCIPITAL LEAD LOCATION. THE PT WAS TREATED WITH ORAL ANTIBIOTICS AND DISCHARGED ON (B)(6) 2013. FOLLOW-UP INFORMATION IDENTIFIED THE PT'S SCS SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40285 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3801364

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R