BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? CX

    MDR report key: 22004014 · Received May 12, 2025

    Report

    Report Number
    3006630150-2025-03266
    Event Type
    Injury
    Date Received
    May 12, 2025
    Date of Event
    February 18, 2025
    Report Date
    April 23, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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. BLOCK D2B: PRO CODE (PRODUCT CODE): QRB ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(6). BATCH: 7070889. UDI: (B)(4). PRODUCT FAMILY: SCS-IPG-R-MRI. UPN: M365SC12320. MODEL: SC-1232. SERIAL: (B)(6). BATCH: 519344. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL MDR IN BLOCKS B5 AND H6.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) LEADS HAD HIGH IMPEDANCES NOTED DURING PROGRAM OPTIMIZATION. IT WAS ALSO MENTIONED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT WORKING AS INTENDED. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE SCS LEADS AND IPG WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED A FALL AT THE SITE OF THE IPG WHICH WAS BELIEVED TO BE THE CAUSE OF IMPEDANCE ISSUES AND RESULTED IN REPLACEMENT OF THE WHOLE SCS SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) LEADS HAD HIGH IMPEDANCES NOTED DURING PROGRAM OPTIMIZATION. IT WAS ALSO MENTIONED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT WORKING AS INTENDED. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE SCS LEADS AND IPG WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) LEADS HAD HIGH IMPEDANCES NOTED DURING PROGRAM OPTIMIZATION. ACCORDING TO THE PHYSICIAN, ONE OF THE LEADS SEEMS TO HAVE LOOSENED FROM A FALL AND SINCE THEN HAS BEEN PROVIDING LESS COMFORTABLE STIMULATION. IT WAS ALSO MENTIONED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT WORKING AS INTENDED. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE SCS LEADS AND IPG WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED A FALL AT THE SITE OF THE IPG WHICH WAS BELIEVED TO BE THE CAUSE OF IMPEDANCE ISSUES AND RESULTED TO REPLACEMENT OF THE WHOLE SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422461 INFINION? CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-50 7077175 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1