BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3962489 · Received July 14, 2014

    Report

    Report Number
    1627487-2014-00422
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 18, 2014
    Report Date
    February 25, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: TWO INCOMPLETE STIM END LEADS WERE RECEIVED LEAD ¿A¿ STIM END SEGMENT 59 CM AND LEAD ¿B¿ STIM END SEGMENT 53 CM LONG. THE COMPLAINT ABOUT ¿INVALID IMPEDANCE/JOLTING SENSATION¿ WAS CONFIRMED. AS RECEIVED, MICROSCOPIC INSPECTION OF THE RETURNED INCOMPLETE LEAD ¿A¿ STIM END SEGMENTS MODEL 3189 REVEALED A KINK WITH BROKEN WIRES WERE OBSERVED APPROXIMATELY 18 CM FROM THE STIM END. THE DAMAGE OBSERVED IS CONSISTENT WITH OVERSTRESS THE LEAD WAS SUBJECTED WHILE THE LEAD WAS IN THE PATIENT. CONTINUITY TEST ON INCOMPLETE LEAD ¿B¿ STIM END SEGMENT PASS THE TEST. 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.

    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.

    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 3 REFERENCE MFR REPORT #S 1627487-2014-00423 AND 1627487-2014-00424 IT WAS REPORTED SURGICAL INTERVENTION WAS UNDERTAKEN ON 01/15/2015 TO EXPLANT AND REPLACE THE PATIENT¿S LEADS AS IMPEDANCE ISSUES REMAINED. BOTH DEVICES WERE REPORTEDLY CUT TO FACILITATE EXPLANT. EFFECTIVE THERAPY WAS RECAPTURED FOR THE PATIENT FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    DEVICE 1 OF 3. REFERENCE MFR REPORT #S 1627487-2014-00423 AND 1627487-2014-00424. IT WAS REPORTED THE PATIENT (B)(6) IS EXPERIENCING INTERMITTENT OVERESTIMATION FROM HER THERAPY SYSTEM. A DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE MEASUREMENTS FOR TWO LEAD CONTACTS. THE PATIENT REPORTEDLY HAS SUFFERED FALLS RECENTLY. X-RAYS WILL BE TAKEN FOR FURTHER INTERROGATION.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2014-00423.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409253 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3189 2810925

    Patients

    Seq Age Sex Outcome Treatment
    1 Other