BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4203353 · Received October 23, 2014

    Report

    Report Number
    1627487-2014-15784
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    August 4, 2014
    Report Date
    October 1, 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
    OK, 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 2 REFERENCE MFR REPORT: 1627487-2014-15785. THE PATIENT REPORTED EXPERIENCING AUTO-REDUCING AS WELL AS POSITIONAL STIMULATION. THE SJM REPRESENTATIVE MET WITH THE PATIENT AND DIAGNOSTICS INDICATED INVALID IMPEDANCE READINGS. REPROGRAMMING WAS INITIALLY ABLE TO PROVIDE EFFECTIVE COVERAGE. THE PATIENT LATER INDICATED HER SCS SYSTEM WAS AGAIN AUTO-REDUCING AND SHE WAS EXPERIENCING POSITIONAL STIMULATION. DIAGNOSTICS AGAIN INDICATED INVALID IMPEDANCE READINGS ON ALL LEAD CONTACTS. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677516 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL ¿ NEUROMODULATION 3186 4248231

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other SCS ANCHOR, MODEL: 1192 (2)| IMPLANT DATE:| SCS IPG, MODEL: 3788| IMPLANT DATE: