BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10518159 · Received September 10, 2020

    Report

    Report Number
    3006630150-2020-04115
    Event Type
    Injury
    Date Received
    September 10, 2020
    Date of Event
    May 20, 2020
    Report Date
    October 21, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE TECHNICAL ANALYSIS: VISUAL INSPECTION OF THE RETURNED IPG SC-1160 SN (B)(6) REVEALED THE MONITORED STIMULATION ON AN OSCILLOSCOPE FOUND THE OUTPUTS WERE CONSISTENT AND CORRECT ON ALL ELECTRODES. CURRENT LEAKAGE TEST AND RESIDUAL GAS ANALYSIS VERIFIED NO LOSS OF ELECTRIC CURRENT INTO THE SURROUNDING TISSUE. THE IPG PASSED ALL THE REQUIRED TESTS AND REVEALED NO ANOMALIES. VISUAL INSPECTION OF THE RETURNED LEAD SC-2317-50 SN (B)(6) REVEALED A NICK ABOUT 15 CENTIMETERS FROM THE PROXIMAL TIP WHERE TWO OF THE CABLES WERE SHARPLY CUT AND EXPOSED. NO ANOMALIES WERE IDENTIFIED ON THE LEAD ASIDE FROM THE CABLE DAMAGE, WHICH IS A RESULT OF TYPICAL EXPLANT PROCEDURE AND IS NOT CONSIDERED A FAILURE. VISUAL AND X-RAY INSPECTION OF THE RETURNED LEAD SC-2317-50 SN 5063366 REVEALED FRACTURED CABLES AT THE CLICK SITE WHERE NO CABLES WERE EXPOSED. THE IMPEDANCE MEASUREMENT TEST CONFIRMED 9 FRACTURED CABLES. INVESTIGATION CONCLUSION: THE INVESTIGATION CONCLUDED THAT THE REPORTED EVENT OF PATIENT UNDERGOING AN EXPLANT PROCEDURE TO REMOVE IPG AND LEADS DUE TO PAIN, DISCOMFORT AND BURNING SENSATION AT THE POCKET SITE, AND NO LONGER RECEIVING ADEQUATE PAIN RELIEF WAS CONFIRMED. THE LEAD GOT KINKED AFTER IT EXITED THE CLIK ANCHOR RESULTING IN THE REPORTED COMPLAINT. IT APPEARS THAT EXCESSIVE MECHANICAL TENSILE FORCE WAS EXERTED ONTO THE LEAD, RESULTING IN THE CABLE FRACTURES. THEREFORE, THE PROBABLE CAUSE IS CAUSE TRACED TO COMPONENT FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE TO REMOVE THE IPG AND LEADS DUE TO PAIN, DISCOMFORT AND A BURNING SENSATION AT THE POCKET SITE AND WAS NO LONGER RECEIVING ADEQUATE PAIN RELIEF. PATIENT WAS STABLE POST OPERATIVELY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 5092440. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 5063366.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE TO REMOVE THE IPG AND LEADS DUE TO PAIN, DISCOMFORT AND A BURNING SENSATION AT THE POCKET SITE AND WAS NO LONGER RECEIVING ADEQUATE PAIN RELIEF. PATIENT WAS STABLE POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978899 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 353669 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention