BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 8696029 · Received June 13, 2019

    Report

    Report Number
    3006630150-2019-02766
    Event Type
    Injury
    Date Received
    June 13, 2019
    Date of Event
    June 18, 2019
    Report Date
    August 22, 2019
    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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT SURGERY AND WAS DOING WELL POST OPERATIVELY. TW 10830937 SC-2317-50 SERIAL 5092381 INFINION CX LEAD KIT 50CM THE ANALYSIS ON THE RETURNED LEAD CONFIRMED HIGH IMPEDANCE. VISUAL AND X-RAY INSPECTION OF THE LEAD REVEALED THAT MULTIPLE CABLES WERE COMPLETELY BROKEN AT THE BENT/KINKED LOCATION OF THE LEAD. THE BENT KINKED LOCATION IS 1 CM FROM THE SET SCREW MARK OF THE CLIK ANCHOR. THERE ARE NO EXPOSED CABLES AT THE FRACTURE LOCATION. THE LEAD GOT KINKED AFTER IT EXITS THE CLIK ANCHOR RESULTING IN THE REPORTED COMPLAINT. TW 11066760 SC-2317-50 SERIAL (B)(4) INFINION CX LEAD KIT 50CM THE ANALYSIS ON THE RETURNED LEAD CONFIRMED HIGH IMPEDANCE. VISUAL AND X-RAY INSPECTION OF THE LEAD REVEALED THAT MULTIPLE CABLES WERE COMPLETELY BROKEN AT THE BENT/KINKED LOCATION OF THE LEAD. THE BENT KINKED LOCATION IS 1 CM FROM THE SET SCREW MARK OF THE CLIK ANCHOR. THERE ARE NO EXPOSED CABLES AT THE FRACTURE LOCATION. THE LEAD GOT KINKED AFTER IT EXITS THE CLIK ANCHOR RESULTING IN THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENTS LEADS DISPLAYED HIGH IMPEDANCES. THE PHYSICIAN SUSPECTS LEAD FRACTURE. THE PATIENT IS SCHEDULED FOR A LEAD REPLACEMENT PROCEDURE AND THE PHYSICIAN PLANS ON REPLACING BOTH OF THE LEADS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT DEVICE: TW 11066760, MODEL SC 2317 50, SERIAL (B)(4), INFINION CX LEAD.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S LEADS DISPLAYED HIGH IMPEDANCES. THE PHYSICIAN SUSPECTS LEAD FRACTURE. THE PATIENT IS SCHEDULED FOR A LEAD REPLACEMENT PROCEDURE AND THE PHYSICIAN PLANS ON REPLACING BOTH OF THE LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489702 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 5092381 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention