BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WIDE-SPACED QUATTRODE PERCUTANEOUS LEAD

    MDR report key: 2041177 · Received March 29, 2011

    Report

    Report Number
    1627487-2011-02378
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 27, 2011
    Report Date
    February 27, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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 2 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2011-02377. THE PT RECEIVED AN SCS SYSTEM, INCLUDING TWO PERCUTANEOUS LEADS, ON (B)(6) 2010. IT WAS REPORTED THE LEADS WERE SURGICALLY REPOSITIONED DUE TO MIGRATION. FOLLOW UP ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIDE-SPACED QUATTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3166 3218964

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCS LEAD EXTENSION: MODEL 3341| SCS LEAD: MODEL 3169| IMPLANT:| SCS IPG: MODEL 3788| IMPLANT:| IMPLANT: