BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3031958 · Received March 28, 2013

    Report

    Report Number
    1627487-2013-15422
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    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. RESULTS: REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT LOT. HOWEVER, THE INDIVIDUAL AFFECTED DEVICE WAS REWORKED AND ALL DEVICES WITHIN THE LOT MET ACCEPTANCE CRITERIA. THEREFORE, THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE COMPLAINT. 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 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-15423. THE PT WAS IMPLANTED WITH 4 LEADS (2 FROM THE SAME LOT AND 2 FROM A DIFFERENT LOT). TWO LEADS WERE PLACED IN THE SUPRA-ORBITAL REGION (OFF-LABEL) AND TWO LEADS WERE PLACED IN THE ORBITAL REGION (OFF-LABEL). IT WAS REPORTED THE PT'S ENTIRE SCS SYSTEM WAS EXPLANTED DUE TO AN INFECTION IN THE PT'S NECK. THE PT WAS GIVEN IV AND ORAL ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127517 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3166 3799317

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3346 (2)