BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 2792182 · Received October 11, 2012

    Report

    Report Number
    1627487-2012-03495
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 17, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: RESULTS: VISUAL INSPECTION OF THE RETURNED LEAD DID NOT REVEAL ANY ANOMALIES. THE LEAD PLACEMENT INDICATOR WAS CORRECTLY ORIENTED. THE STIMULATION ENDS, LEAD BODIES, AND TERMINAL ENDS WERE IN GOOD CONDITION. A LAB STYLET WAS INSERTED INTO THE LEAD NORMALLY. CONTINUITY TESTING WAS PERFORMED TO ANALYZE THE CHANNELS' RESISTANCE AND TO VERIFY THE INSULATION CHARACTERISTICS BETWEEN CHANNELS. DOCUMENT (B)(6) INDICATES THAT THE CHANNELS SHOULD MEASURE LESS THAN 4 OHMS. TESTING THE LEADS PER PROCEDURE (B)(6) REVEALED SEVERAL CHANNELS FAILED CONTINUITY TESTING PER THE FOLLOWING RESULTS: CHANNEL 1: OPEN, CHANNEL 2: OPEN, CHANNEL 3: OPEN, CHANNEL 4: OPEN, CHANNEL 5: OPEN, CHANNEL 6: OPEN, CHANNEL 7: 3.06 OHMS, CHANNEL 8: 3.04 OHMS. NO INTERCHANNEL ANOMALIES WERE OBSERVED. MICROSCOPIC INSPECTION OF THE FAILING CHANNELS REVEALED THE CONDUCTING WIRES WERE DISCONNECTED FROM THE STIM ELECTRODES CONSISTENT WITH OVERSTRESSING. CONCLUSION: THE COMPLAINT THAT THE LEAD COULD NOT BE IMPLANTED WAS NOT CONFIRMED. AS RECEIVED, VISUAL INSPECTION OF THE LEAD DID NOT REVEAL ANY ANOMALIES. FUNCTIONAL TESTS REVEALED CHANNELS 1 THROUGH 6 WERE OPEN. MICROSCOPIC INSPECTION REVEALED THE CONDUCTING WIRES HAD DISCONNECTED FROM THE STIM ELECTRODES CONSISTENT WITH OVERSTRESSING. 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 THAT DURING THE PT'S PERMANENT PROCEDURE THE PHYSICIAN WAS NOT ABLE TO ADVANCE THE SCS LEAD THROUGH THE EPIDUCER. SUBSEQUENTLY, THE PHYSICIAN COMPLETED THE PROCEDURE WITH 3 OTHER SCS LEADS. THE PROCEDURE WAS EXTENDED BY APPROXIMATELY 1 HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE S8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3286 3715645

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention