BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2792108 · Received October 12, 2012

    Report

    Report Number
    1627487-2012-06541
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 17, 2012
    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

    IT WAS REPORTED THE PT'S SCS SYSTEM WAS EXPLANTED DUE TO AN INFECTION AT THE LEAD SITE. CULTURES WERE TAKEN AND REVEALED A (B)(6). THE PT IS BEING TREATING WITH ORAL AND IV ANTIBIOTICS. THE PT IS DOING WELL AND HEALING PROPERLY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3763119

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention IMPLANT:| EXPLANT:| SCS IPG: MODEL: 3788