BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2902976 · Received December 26, 2012

    Report

    Report Number
    1627487-2012-16012
    Event Type
    Injury
    Date Received
    December 26, 2012
    Date of Event
    September 28, 2011
    Report Date
    September 28, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    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

    IT WAS REPORTED, THE PATIENT WAS EXPERIENCING RIB STIMULATION AND INADEQUATE COVERAGE. THE DOCTOR DETERMINED THE LEAD WAS STIMULATING THE PATIENT'S NERVE ROOT. THE DOCTOR ALSO DETERMINED THE PATIENT'S EPIDURAL SPACE HAD AN ODD SHAPE THAT CONTRIBUTED TO RIB STIMULATION. AS A RESULT, THE LEAD WAS EXPLANTED AND REPLACED WITH TWO LEADS (DIFFERENT MODEL). THE REPLACEMENT LEADS RESOLVED THE PATIENT'S ISSUE. THE EXPLANTED PRODUCT WILL NOT BE RETURNED TO SJM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3439212

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention IMPLANT DATE:| SCS IPG, MODEL 3788