BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION? CX

    MDR report key: 24847361 · Received April 11, 2026

    Report

    Report Number
    3006630150-2026-02242
    Event Type
    Malfunction
    Date Received
    April 11, 2026
    Date of Event
    February 17, 2026
    Report Date
    May 11, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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: PRODUCT CODE: QRB. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2317-50. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 3121995. MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D2B: PRODUCT CODE: QRB. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2317-50, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 3121995, MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM, UNIQUE IDENTIFIER (UDI) #: (B)(4). INVESTIGATION RESULTS; DEVICE NOT RETURNED; NO ANALYSIS PERFORMED. COMPLAINT NOT CONFIRMED THROUGH PHYSICAL EVALUATION. DEVICE HISTORY RECORD (DHR): A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE DEVICE MET ALL REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. NO MANUFACTURING DEVIATIONS, NONCONFORMANCES, OR PROCESS ANOMALIES WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. LABELING REVIEW: A REVIEW OF THE DEVICE LABELING WAS PERFORMED AND FOUND TO BE ADEQUATE. THE LABELING CONTAINS APPROPRIATE INSTRUCTIONS FOR USE AND DOES NOT INDICATE ANY DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. INVESTIGATION CONCLUSION: DUE TO THE UNAVAILABILITY OF THE DEVICE FOR ANALYSIS AND THE INABILITY TO CONFIRM THE REPORTED ISSUE THROUGH RECORD REVIEW, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THERE WAS NO EVIDENCE IDENTIFIED FROM MANUFACTURING OR LABELING REVIEWS THAT WOULD SUGGEST A CONTRIBUTING FACTOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT SPINAL CORD STIMULATION (SCS) LEAD HAS HIGH IMPEDANCES. LEAD FRACTURED WAS NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT SPINAL CORD STIMULATION (SCS) LEAD HAS HIGH IMPEDANCES. LEAD FRACTURED WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59010 INFINION? CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-50 20014786 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1