BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION? CX

    MDR report key: 22302938 · Received June 20, 2025

    Report

    Report Number
    3006630150-2025-04748
    Event Type
    Malfunction
    Date Received
    June 20, 2025
    Date of Event
    February 22, 2025
    Report Date
    April 30, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7082845, UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    SECTION B3: DATE OF EVENT UNKNOWN. APPROXIMATED 1-2 MONTHS PRIOR THE MANUFACTURER BECOMING AWARE OF THE EVENT. SECTION B5 DESCRIBE EVENT OR PROBLEM UPDATED. SECTION D2B ADDITIONAL PRO CODE, QRB. SECTION H6 FIELDS UPDATED. SECTION E1 INITIAL REPORTER EMAIL UPDATED. SECTION H6 FIELDS UPDATED. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 70CM MODEL: SC-2317-70 SERIAL: (B)(6). BATCH: 7082845 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEFT SPINAL CORD STIMULATION (SCS) LEAD WAS OUT. THE PATIENT UNDERWENT LEAD REPLACEMENT. DURING POST OPERATION VISIT THE PATIENT WAS EXPERIENCING UNDESIRED STIMULATION TO THE RIGHT BREAST AND STIMULATION. DURING PROGRAMMING SESSION RIGHT LEAD WAS GRABBING ALL IN THE RIGHT BREAST AND CHEST AREA AND HAD TO BE TURNED OFF. REP WAS ABLE TO GET SOME LEFT COVERAGE ON THE LEFT LEAD, BUT IT WAS MOSTLY COVERING RIGHT. NO FURTHER INTERVENTION PLANNED AT THIS TIME. NO FURTHER INFORMATION HAS BEEN OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEFT SPINAL CORD STIMULATION (SCS) LEAD WAS OUT AND WAS FRACTURED. THE PATIENT UNDERWENT LEAD REPLACEMENT. DURING POST OPERATION VISIT THE PATIENT WAS EXPERIENCING UNDESIRED STIMULATION TO THE RIGHT BREAST AND STIMULATION. DURING PROGRAMMING SESSION RIGHT LEAD WAS GRABBING ALL IN THE RIGHT BREAST AND CHEST AREA AND HAD TO BE TURNED OFF. REP WAS ABLE TO GET SOME LEFT COVERAGE ON THE LEFT LEAD, BUT IT WAS MOSTLY COVERING RIGHT. NO FURTHER INTERVENTION PLANNED AT THIS TIME. NO FURTHER INFORMATION HAS BEEN OBTAINED. ADDITIONAL INFORMATION RECEIVED STATED THAT EXPLANTED PRODUCT WAS RETAINED BY FACILITY AND WILL NOT BE RELEASED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEFT SPINAL CORD STIMULATION (SCS) LEAD WAS OUT. THE PATIENT UNDERWENT LEAD REPLACEMENT. DURING POST OPERATION VISIT THE PATIENT WAS EXPERIENCING UNDESIRED STIMULATION TO THE RIGHT BREAST. DURING PROGRAMMING SESSION RIGHT LEAD WAS GRABBING ALL IN THE RIGHT BREAST AND CHEST AREA AND HAD TO BE TURNED OFF. REP WAS ABLE TO GET SOME LEFT COVERAGE ON THE LEFT LEAD, BUT IT WAS MOSTLY COVERING RIGHT. NO FURTHER INTERVENTION PLANNED AT THIS TIME. NO FURTHER INFORMATION HAS BEEN OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EXPLANTED DEVICE WAS RETAINED BY FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315022 INFINION? CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-70 7085664 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention