BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2844552 · Received November 16, 2012

    Report

    Report Number
    1627487-2012-14046
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 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

    EVAL: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2012-14045. IT WAS REPORTED, THE PT'S INCISION SITE WAS RED AND HAD PUS COMING OUT. THE PHYSICIAN DETERMINED THE PT HAD AN INFECTION AND TREATED HER WITH ORAL ANTIBIOTICS. F/U INFO IDENTIFIED THE PT'S ENTIRE SCS SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3741498

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention SCS ANCHOR: MODEL 1194 (2)| IMPLANT: