BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION CX

    MDR report key: 10756705 · Received October 29, 2020

    Report

    Report Number
    3006630150-2020-05249
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Date of Event
    November 1, 2019
    Report Date
    October 29, 2020
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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: 5032523.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IPG REVISION PROCEDURE (MFR REPORT NUMBER 3006630150-2019-06679), IT WAS FOUND OUT THAT THE PATIENTS LEADS HAD HIGH IMPEDANCES AND UNKNOWN IF IT WAS DUE TO A NON-DEVICE RELATED FALL. THE PATIENT UNDERWENT A REPLACEMENT PROCEDURE AND FOUND OUT THAT THE LEAD WAS FRACTURED. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND EXPLANTED LEADS WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220608 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 5031871 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention