BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2852310 · Received November 27, 2012

    Report

    Report Number
    1627487-2012-06820
    Event Type
    Injury
    Date Received
    November 27, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Product Problem
    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

    REFERENCE MFR. REPORT#: 1627487-2012-06818, 06819. THE PATIENT HAD TWO LEADS (FROM THE SAME LOT). IT WAS REPORTED STIMULATION WAS NOT PROVIDING PAIN RELIEF FOR THE PATIENT. AS A RESULT, THE PATIENT'S SCS SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3166 3215375

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention EXPLANT:| EXPLANT:| IMPLANT:| SCS EXTENSIONS, MODEL: 3346 (2)| IMPLANT:| SCS IPG, MODEL: 3788