BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCHOR

    MDR report key: 3150072 · Received May 30, 2013

    Report

    Report Number
    1627487-2013-04669
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 7, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    K092371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEW 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 3 OF 3. REFERENCE MFR REPORT: 1627487-2013-04661, 1627487-2013-04662. IT WAS REPORTED THE PT HAD GONE TO THE EMERGENCY ROOM ON THE NIGHT OF (B)(6) 2013 DUE TO PAIN. IT WAS REPORTED THE PT HAD BEEN PLACED ON ANTIBIOTICS THE SAME DAY AT THE PHYSICIAN'S OFFICE APPOINTMENT. F/U IDENTIFIED THE SCS SYSTEM WAS EXPLANTED, AND THE PT'S WIFE REPORTED THE HOSP PERSONNEL TOLD HER THE PT MAY HAVE BACTERIA MENINGITIS. FURTHER F/U IDENTIFIED THE PT WAS RECEIVING HOME HEALTH CARE EACH DAY AND WAS PLACED ON IV ANTIBIOTICS. IT WAS REPORTED THE PT HAD INCREASED WELLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237835 ANCHOR SCS ANCHOR LGW ST. JUDE MEDICAL - NEUROMODULATION 1192 4000132

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R