BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOCTRODE

    MDR report key: 4142884 · Received September 23, 2014

    Report

    Report Number
    1627487-2014-08303
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 4, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    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 INFO 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 HAD INVALID IMPEDANCE READINGS ON HER SCS THORACIC LEAD. A SJM REP MET WITH THE PATIENT AND CONFIRMED THE LEAD WAS INVALID. SURGICAL INTERVENTION IS PLANNED FOR A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590878 IOCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4382044

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other SCS IPG: MODEL, 3788| SCS LEAD: MODEL, 3189| IMPLANT DATE:| IMPLANT DATE: