BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 3764402 · Received April 9, 2014

    Report

    Report Number
    1627487-2014-00187
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    February 24, 2014
    Report Date
    March 14, 2014
    Manufacturer
    ST. JUDE MEDICAL- NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    THE PT (B)(6) IS A PARTICIPANT IN A CLINICAL STUDY. IT WAS REPORTED THE PT WAS IMPLANTED WITH A LEAD ON (B)(6) 2014 TO REPLACE TO DEVICE PREVIOUSLY EXPLANTED (REFERENCE MFR REPORT NUMBER: 162487-2014-00186). AN INFECTION WAS REPORTEDLY DETECTED. THE WOUND WAS TREATED AND ANTIBIOTICS WERE ADMINISTERED TO THE PT ON (B)(6) 2014. THE REPORTED ISSUE HAS NOT RESOLVED. ATTEMPTS TO OBTAIN CLARITY AND ADD'L DETAILS REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212925 UNK SCS LEAD GZB ST. JUDE MEDICAL- NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other