BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 11375476 · Received February 24, 2021

    Report

    Report Number
    3006630150-2021-00619
    Event Type
    Injury
    Date Received
    February 24, 2021
    Date of Event
    January 21, 2021
    Report Date
    May 19, 2021
    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
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXPLANTED LEAD SC-2317-70, SERIAL NUMBER (B)(6) WAS RETURNED AND ANALYZED. VISUAL (MICROSCOPE) AND X-RAY INSPECTION OF THE LEAD REVEALED THAT MULTIPLE CABLES WERE COMPLETELY BROKEN AT THE BENT LOCATION OF THE LEAD. THE BENT LOCATION IS 2 CM FROM THE SET SCREW MARK OF THE CLIK X ANCHOR. THERE ARE NO EXPOSED CABLES AT THE FRACTURE LOCATION. THE LEAD BECAME KINKED AFTER IT EXITS THE CLIK X ANCHOR RESULTING IN THE REPORTED COMPLAINT. BASED ON ALL AVAILABLE INFORMATION, ENGINEERS CONCLUDED THAT INADEQUATE STIMULATION AND HIGH IMPEDANCE MEASUREMENTS WERE CAUSED BY A LEAD FRACTURE. THE LEAD BECAME BENT/KINKED AFTER EXITING THE CLIK ANCHOR WHICH EXPOSED THE BENT LOCATION TO EXCESSIVE MECHANICAL FORCE OR MOVEMENT THAT CAUSED THE LEAD CABLES TO FRACTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO HIGH IMPEDANCES DISPLAYED ON THE LEAD FROM THE RIGHT SIDE. THE PATIENT'S DEVICE WAS REPROGRAMMED, HOWEVER, THE ISSUE DID NOT RESOLVE. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POST-OPERATIVELY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2317700; MODEL: SC-2317-70; SERIAL: (B)(4); LOT: 5112744.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED LEAD SC-2317-70, SERIAL NUMBER (B)(4) WAS RETURNED AND ANALYZED. VISUAL (MICROSCOPE) AND X-RAY INSPECTION OF THE LEAD REVEALED THAT MULTIPLE CABLES WERE COMPLETELY BROKEN AT THE BENT LOCATION OF THE LEAD. THE BENT LOCATION IS 2 CM FROM THE SET SCREW MARK OF THE CLIK X ANCHOR. THERE ARE NO EXPOSED CABLES AT THE FRACTURE LOCATION. THE LEAD BECAME KINKED AFTER IT EXITS THE CLIK X ANCHOR RESULTING IN THE REPORTED COMPLAINT. BASED ON ALL AVAILABLE INFORMATION, ENGINEERS CONCLUDED THAT INADEQUATE STIMULATION AND HIGH IMPEDANCE MEASUREMENTS WERE CAUSED BY A LEAD FRACTURE. THE LEAD BECAME BENT/ KINKED AFTER EXITING THE CLIK ANCHOR WHICH EXPOSED THE BENT LOCATION TO EXCESSIVE MECHANICAL FORCE OR MOVEMENT THAT CAUSED THE LEAD CABLES TO FRACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO HIGH IMPEDANCES DISPLAYED ON THE LEAD FROM THE RIGHT SIDE. THE PATIENT'S DEVICE WAS REPROGRAMMED, HOWEVER, THE ISSUE DID NOT RESOLVE. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POST-OPERATIVELY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO HIGH IMPEDANCES DISPLAYED ON THE LEAD FROM THE RIGHT SIDE. THE PATIENT'S DEVICE WAS REPROGRAMMED, HOWEVER, THE ISSUE DID NOT RESOLVE. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE WHERE ONE LEAD WAS REPLACED. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268142 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 5113501 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention