BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 11499700 · Received March 16, 2021

    Report

    Report Number
    3006630150-2021-01027
    Event Type
    Injury
    Date Received
    March 16, 2021
    Date of Event
    February 17, 2021
    Report Date
    May 11, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE TECHNICAL ANALYSIS: A REVIEW OF THE MANUFACTURING RECORDS ASSOCIATED WITH THE LEAD MODEL SC-2317-70 SERIAL NUMBER (B)(6) INDICATED THAT IT WAS SUCCESSFULLY PROCESSED ACCORDING TO REQUIREMENTS. THE DHR DID NOT IDENTIFY ANY MANUFACTURING PROCESS-RELATED NON-CONFORMANCES, SCRAP, OR REWORK PERFORMED DURING PRODUCTION THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. THE DHR REVIEW ENSURES EACH DEVICE MEETS REQUIRED SPECIFICATIONS AND ASSOCIATED TESTING PRIOR TO RELEASE FOR DISTRIBUTION/SALE. INVESTIGATION CONCLUSION: BASED ON ALL AVAILABLE INFORMATION, ENGINEERS CONCLUDED THAT THE HIGH IMPEDANCE AND INTERMITTENT STIMULATION MEASUREMENTS WERE CAUSED BY A LEAD FRACTURE. THE LEAD BECAME BENT AFTER EXITING THE CLIK X ANCHOR WHICH EXPOSED THE BENT LOCATION TO EXCESSIVE MECHANICAL FORCE OR MOVEMENT THAT CAUSED THE LEAD CABLES TO FRACTURE.

    Additional Manufacturer Narrative · 0

    D6A: IMPLANT DATE - APPROXIMATE, IMPLANT DATE (B)(6) 2020. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138350, MODEL: SC-3138-35, SERIAL: (B)(6), BATCH/LOT: 7063379. PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138350, MODEL: SC-3138-35, SERIAL: (B)(6), BATCH/LOT: 7062991.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCES AND UNDERWENT A REVISION PROCEDURE. THE PATIENT IS DOING WELL POST-OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCES AND UNDERWENT A REVISION PROCEDURE. THE PATIENT IS DOING WELL POST-OPERATIVELY.

    Additional Manufacturer Narrative · 1

    IMPLANT DATE - APPROXIMATE, IMPLANT DATE (B)(6) 2020.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCES AND UNDERWENT A REVISION PROCEDURE. THE PATIENT IS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394973 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 5178630 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention