BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3221608 · Received July 9, 2013

    Report

    Report Number
    1627487-2013-12916
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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. REFERENCE MFR REPORT #1627487-2013-12917, 12918, 12919. IT WAS REPORTED THE INCISION ON THE PATIENT'S BACK OPENED. THE PHYSICIAN DID NOT BELIEVE THE WOUND WAS INFECTED. THE PHYSICIAN THOUGHT IT MAY BE AN ALLERGIC REACTION. THE SCS SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312816 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3166 3597329

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other SCS EXTENSION: MODEL 3341 (2)| IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE: