BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLIK X

    MDR report key: 10111004 · Received June 2, 2020

    Report

    Report Number
    3006630150-2020-02289
    Event Type
    Injury
    Date Received
    June 2, 2020
    Date of Event
    May 14, 2020
    Report Date
    July 22, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905318
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE TECHNICAL ANALYSIS: VISUAL INSPECTION OF THE RETURNED CLIK ANCHOR REVEALED THE DISTAL ENDS WERE SHORTENED BY 11-12 MM, AND THE CUT PORTIONS WERE NOT RETURNED. IT APPEARED THAT THE DEVICE CUT WAS MADE DURING THE EXPLANT PROCEDURE AND WAS NOT CONSIDERED A FAILURE. VISUAL INSPECTION OF THE RETURNED IPG REVEALED THE MONITORED STIMULATION ON AN OSCILLOSCOPE FOUND THE OUTPUTS WERE CONSISTENT AND CORRECT ON ALL ELECTRODES. AC DC CURRENT LEAKAGE TESTS AND RESIDUAL GAS ANALYSIS VERIFIED NO LOSS OF ELECTRIC CURRENT INTO THE SURROUNDING TISSUE. IT PASSED THE FUNCTIONAL TEST AND REVEALED NO ANOMALIES. VISUAL INSPECTION OF THE RETURNED LEADS REVEALED THE LEADS WERE CLEANLY CUT. THE DAMAGE ON THE DEVICES WAS SIMILAR TO THE TYPICAL EXPLANT DAMAGE AND WAS NOT CONSIDERED A FAILURE. INVESTIGATION CONCLUSION BASED ON THE PROVIDED INFORMATION, THE COMPLAINT OF PAIN AT THE LEAD IMPLANT SITE AND IPG POCKET SITE WAS NOT CONFIRMED. THE PROBABLE CAUSE IS NO PROBLEM DETECTED. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7071032. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7071060. PRODUCT FAMILY: SCS-IPG-R, UPN: M365SC11600, MODEL: SC-1160, SERIAL: (B)(6), BATCH: 362109.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE LEAD IMPLANT INCISION SITE. IMAGING DISPLAYED A PROMINENT KNOT AT THE TOP OF THE INCISION SITE OF THE LEADS. THE PHYSICIAN SUSPECTED THE CLIK ANCHOR WAS THE CAUSE OF THE LEAD SITE PAIN SINCE THE SYSTEM HAD NOT YET BEEN ACTIVATED. PER THE PATIENTS REQUEST, SHE UNDERWENT A SYSTEM EXPLANT PROCEDURE DUE TO PAIN AT THE LEAD SITE AND THE IPG POCKET SITE. THE PATIENT IS DOING WELL 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-2317-70, SERIAL: (B)(4), BATCH: 7071032. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2317-70, SERIAL: (B)(4), BATCH: 7071060. PRODUCT FAMILY: SCS-IPG-R, UPN: (B)(4), MODEL: SC-1160, SERIAL: (B)(4), BATCH: 362109.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE LEAD IMPLANT INCISION SITE. IMAGING DISPLAYED A PROMINENT KNOT AT THE TOP OF THE INCISION SITE OF THE LEADS. THE PHYSICIAN SUSPECTED THE CLIK ANCHOR WAS THE CAUSE OF THE LEAD SITE PAIN SINCE THE SYSTEM HAD NOT YET BEEN ACTIVATED. PER THE PATIENTS REQUEST, SHE UNDERWENT A SYSTEM EXPLANT PROCEDURE DUE TO PAIN AT THE LEAD SITE AND THE IPG POCKET SITE. THE PATIENT IS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573201 CLIK X STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-4318 24900585 08714729905318

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention