BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE

    MDR report key: 3010813 · Received March 14, 2013

    Report

    Report Number
    1627487-2013-01280
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ST. JUDE MEDICAL- NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE COMPLAINT FOR INVALID IMPEDANCE WAS CONFIRMED. THE INTER-CHANNEL IMPEDANCE SHOWS RESISTANCE VALUE INSTEAD OF OPEN INDICATION OR CHANNEL TO BE ISOLATED FROM ONE ANOTHER. ISSUE RELATED TO PACKAGE LEVEL, (B)(4), DHR REVIEW IS REQUIRED. REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT LOT. THE INDIVIDUAL AFFECTED DEVICE WAS REMOVED FROM THE LOT. ALL OTHER DEVICES WITHIN THE LOT MET ACCEPTANCE CRITERIA. THEREFORE THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE COMPLAINT. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFO 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

    IT WAS REPORTED DURING A PERMANENT IMPLANT PROCEDURE ON (B)(6) 2013 THE PATIENT'S LEAD SHOWED INVALID IMPEDANCES. THE PHYSICIAN REMOVED THE LEAD AND REPLACED IT WITH A NEW ONE. SOME CONTACTS ON THE NEW LEAD HAD HIGH IMPEDANCES, BUT AN SJM REP WAS ABLE TO PROGRAM AROUND THEM. THE PATIENT HAS GOOD COVERAGE AND EFFECTIVE STIMULATION. THE SURGICAL PROCEDURE WAS EXTENDED BY 30-45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108356 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL- NEUROMODULATION 3186 3861965

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention