BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 17334027 · Received July 17, 2023

    Report

    Report Number
    3006630150-2023-04158
    Event Type
    Injury
    Date Received
    July 17, 2023
    Date of Event
    June 15, 2023
    Report Date
    September 19, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6), BATCH: 7072956.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317500 MODEL: SC-2317-50 SERIAL: (B)(6) BATCH: (B)(6). VISUAL INSPECTION OF LEADS SC-2317-50, SERIAL NUMBER (B)(6) REVEALED THAT THE LEADS WERE CLEANLY CUT INTO TWO PIECES 35CM FROM THE DISTAL ENDS OF THE LEADS. THE CLEAN-CUTS ARE A RESULT OF TYPICAL EXPLANT PROCEDURE AND ARE NOT CONSIDERED FAILURES. TESTING OF THE LEADS COULD NOT CONFIRM LEAD MIGRATION OR HIGH IMPEDANCES. NO OTHER ANOMALIES WERE IDENTIFIED ON THE RETURNED LEADS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE DUE TO HIGH IMPEDANCES AND LEAD MIGRATION. THE PATIENT WAS DOING WELL POST-OPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE REVISION PROCEDURE, TWO LEADS WERE REPLACED. THE SECOND LEAD WAS REPLACED DUE TO LEAD MIGRATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE DUE TO HIGH IMPEDANCES AND LEAD MIGRATION. THE PATIENT WAS DOING WELL POST-OPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE REVISION PROCEDURE, TWO LEADS WERE REPLACED. THE SECOND LEAD WAS REPLACED DUE TO LEAD MIGRATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE DUE TO HIGH IMPEDANCES AND LEAD MIGRATION. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703971 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 7072958 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention