BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2850110 · Received November 27, 2012

    Report

    Report Number
    1627487-2012-11710
    Event Type
    Injury
    Date Received
    November 27, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 30, 2012
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K072462
    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. RESULT - THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS 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 PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 4: REF MFR REPORT: 1627487-2012-11711, -11712, -11713. IT WAS REPORTED THE PT HAD AN INFECTION AT THE LEAD SITE IN HER FOREHEAD (OFF-LABEL USE). A CULTURE WAS TAKEN WHICH REVEALED A STAPH INFECTION. THE PHYSICIAN PLACED THE PT ON IV ANTIBIOTICS. IT WAS REPORTED THE PHYSICIAN EXPLANTED THE SCS SYSTEM. THE PT HAD BEEN REFERRED TO ANOTHER PHYSICIAN FOR POSTOPERATIVE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE SCS LEAD GZB ST JUDE MEDICAL - NEUROMODULATION 3169 3571262

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention SCS EXTENSION: MODEL 3343 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3716