BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION CX

    MDR report key: 10370738 · Received August 5, 2020

    Report

    Report Number
    3006630150-2020-03259
    Event Type
    Malfunction
    Date Received
    August 5, 2020
    Date of Event
    July 16, 2020
    Report Date
    May 23, 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
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PHYSICIAN BELIEVED THAT THE PATIENTS LEAD WAS FRACTURED. HIGH IMPEDANCE WAS ALSO REPORTED. THE PATIENT WILL UNDERGO A REVISION PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PHYSICIAN BELIEVED THAT THE PATIENTS LEAD WAS FRACTURED. HIGH IMPEDANCE WAS ALSO REPORTED. THE PATIENT WILL UNDERGO A REVISION PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 7070929.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN BELIEVED THAT THE PATIENTS LEAD WAS FRACTURED. HIGH IMPEDANCE WAS ALSO REPORTED. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830298 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 7070806 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention