BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 12791581 · Received November 10, 2021

    Report

    Report Number
    3006630150-2021-06366
    Event Type
    Injury
    Date Received
    November 10, 2021
    Date of Event
    December 24, 2020
    Report Date
    February 1, 2022
    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
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: WITH THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDED THROUGH LABORATORY ANALYSIS THAT INADEQUATE STIMULATION AND HIGH IMPEDANCE MEASUREMENTS WERE CAUSED BY SEVEN CABLE LEAD FRACTURES AT THE CLIK SITE, APPROXIMATELY 19 CENTIMETERS FROM THE DISTAL END. INVESTIGATION CONCLUSION: BASED ON ALL AVAILABLE INFORMATION, ENGINEERS CONCLUDED THAT THE INADEQUATE STIMULATION AND HIGH IMPEDANCE MEASUREMENTS WERE CAUSED BY A LEAD FRACTURE. THE LEAD HAD SEVEN CABLE LEAD FRACTURES AT THE CLIK SITE, APPROXIMATELY 19 CENTIMETERS FROM THE DISTAL END. THE LEAD BECAME BENT AFTER EXITING THE CLIK ANCHOR WHICH EXPOSED THE BENT LOCATION TO EXCESSIVE MECHANICAL FORCE OR MOVEMENT THAT CAUSED THE LEAD CABLES TO FRACTURE. THEREFORE, THE PROBABLE CAUSE OF THE INADEQUATE STIMULATION AND HIGH IMPEDANCE WAS THE ADVERSE EVENT RELATED TO PATIENT CONDITION.

    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)(4), BATCH: 7072785.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEADS WERE DAMAGED DURING A FALL THE PATIENT SUSTAINED ONE WEEK POST IMPLANT. FOLLOWING THE FALL THE PATIENT EXPERIENCED HIGH IMPEDANCES AND INADEQUATE STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE OF BOTH LEADS AND HAS EXPERIENCED NO COMPLICATIONS POST-OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEADS WERE DAMAGED DURING A FALL THE PATIENT SUSTAINED ONE WEEK POST IMPLANT. FOLLOWING THE FALL THE PATIENT EXPERIENCED HIGH IMPEDANCES AND INADEQUATE STIMULATION. THE PATIENT UNDERWENT A PROCEDURE TO EXPLANT BOTH LEADS AND HAS EXPERIENCED NO COMPLICATIONS POST-OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEADS WERE DAMAGED DURING A FALL THE PATIENT SUSTAINED ONE WEEK POST IMPLANT. FOLLOWING THE FALL THE PATIENT EXPERIENCED HIGH IMPEDANCES AND INADEQUATE STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE OF BOTH LEADS AND HAS EXPERIENCED NO COMPLICATIONS POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1683453 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 7003574 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention