BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION CX

    MDR report key: 10668899 · Received October 13, 2020

    Report

    Report Number
    3006630150-2020-04812
    Event Type
    Malfunction
    Date Received
    October 13, 2020
    Date of Event
    February 24, 2020
    Report Date
    October 28, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEAD WAS FRACTURED AND HAD HIGH IMPEDANCES WHICH IMPACTED PATIENT THERAPY. THE PATIENT WILL UNDERGO A REVISION PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WILL BE RETURNED.

    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: M365SC2317700; MODEL: SC-2317-70; SERIAL: (B)(4). BATCH: 5070336.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS LEAD WAS FRACTURED, AND HAD HIGH IMPEDANCES, WHICH IMPACTED PATIENT THERAPY. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136343 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 5120128 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention