BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION CX

    MDR report key: 21164450 · Received January 15, 2025

    Report

    Report Number
    3006630150-2024-09536
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Date of Event
    November 11, 2024
    Report Date
    February 11, 2025
    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
    NE, US
    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: 7072438.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R, UPN: M365SC11600, MODEL: SC-1160, SERIAL: (B)(6), BATCH: 371795.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEADS WERE FRACTURED, HOWEVER, IMAGING WAS NOT TAKEN TO CONFIRM THE ISSUE. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEADS WERE FRACTURED, HOWEVER, IMAGING WAS NOT TAKEN TO CONFIRM THE ISSUE. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEADS HAD MULTIPLE CONTACTS OUT AND THE PATIENT WAS NOT GETTING ENOUGH PAIN RELIEF. THE PATIENT WAS ALSO EXPERIENCING DISCOMFORT AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM REPLACEMENT PROCEDURE AND A MAGNETIC RESONANCE IMAGING (MRI) COMPATIBLE DEVICE WAS IMPLANTED. THE EXPLANTED DEVICE WAS KEPT BY THE MEDICAL FACILITY AND THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253624 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-50 7071816 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention