BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLIK X

    MDR report key: 13691910 · Received March 8, 2022

    Report

    Report Number
    3006630150-2022-00883
    Event Type
    Injury
    Date Received
    March 8, 2022
    Date of Event
    February 15, 2022
    Report Date
    April 29, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905318
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(4), BATCH: 7073221.

    Additional Manufacturer Narrative · 0

    CORRECTION TO FIELD H6: IMPACT CODES. BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2352700. MODEL: SC-2352-70. SERIAL: (B)(6). BATCH: 7073221.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEW DAYS AFTER THE TRIAL IMPLANT THE PHYSICIAN OBSERVED LIQUID CLUSTERING AT THE CLIK ANCHOR LOCATION IN THE BACK. THE PHYSICIAN KEPT THE PATIENT UNDER OBSERVATION FOR TWO WEEKS BEFORE DECIDING TO EXPLANT THE CLIK ANCHOR AND THE LEAD. NO INFECTION WAS DETECTED, BUT THE PATIENT WAS GIVEN ANTIBIOTICS DURING THE PROCEDURE. THE SYMPTOMS SUBSIDED FOLLOWING THE EXPLANT, AND THE PATIENT IS DOING WELL POSTOPERATIVELY. THE DEVICES WERE RETAINED BY THE FACILITY AND WERE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEW DAYS AFTER THE TRIAL IMPLANT THE PHYSICIAN OBSERVED LIQUID CLUSTERING AT THE CLIK ANCHOR LOCATION IN THE BACK. THE PHYSICIAN KEPT THE PATIENT UNDER OBSERVATION FOR TWO WEEKS BEFORE DECIDING TO EXPLANT THE CLIK ANCHOR AND THE LEAD. NO INFECTION WAS DETECTED, BUT THE PATIENT WAS GIVEN ANTIBIOTICS DURING THE PROCEDURE. THE SYMPTOMS SUBSIDED FOLLOWING THE EXPLANT, AND THE PATIENT IS DOING WELL POSTOPERATIVELY. THE DEVICES WERE RETAINED BY THE FACILITY AND WERE NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655111 CLIK X STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-4318 28051430 08714729905318

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention