BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 16109494 · Received January 5, 2023

    Report

    Report Number
    3006630150-2022-07524
    Event Type
    Injury
    Date Received
    January 5, 2023
    Date of Event
    December 9, 2022
    Report Date
    March 14, 2023
    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
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2317700; MODEL: SC-2317-70; SERIAL: (B)(4); BATCH: 7073316.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED UNWANTED STIMULATION IN THE RIGHT SIDE OF HIS BODY WHEN ONLY HIS LEFT SIDE NEEDED COVERAGE. REPROGRAMMING WAS ATTEMPTED HOWEVER, IT DID NOT RESOLVE THE PATIENTS INADEQUATE STIMULATION. X-RAY IMAGING WAS TAKEN TO CONFIRM THE LEADS PLACEMENT. ONE LEAD HAD MIGRATED THEREFORE, THE PATIENT UNDERWENT A LEAD REVISION WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. IT IS UNKNOWN WHICH LEAD SERIAL NUMBER WAS EXPLANTED AND THE LEAD WILL NOT BE RETURNED AS IT WAS DISPOSED OF BY THE MEDICAL FACILITY. THE PATIENT HAS FULLY RECOVERED POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED UNWANTED STIMULATION IN THE RIGHT SIDE OF HIS BODY WHEN ONLY HIS LEFT SIDE NEEDED COVERAGE. REPROGRAMMING WAS ATTEMPTED HOWEVER, IT DID NOT RESOLVE THE PATIENTS INADEQUATE STIMULATION. X-RAY IMAGING WAS TAKEN TO CONFIRM THE LEADS PLACEMENT. ONE LEAD HAD MIGRATED THEREFORE, THE PATIENT UNDERWENT A LEAD REVISION WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. IT IS UNKNOWN WHICH LEAD SERIAL NUMBER WAS EXPLANTED AND THE LEAD WILL NOT BE RETURNED AS IT WAS DISPOSED OF BY THE MEDICAL FACILITY. THE PATIENT HAS FULLY RECOVERED POSTOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT CLARIFIED IT WAS THE PHYSICIANS PREFERENCE TO REPLACE THE LEAD INSTEAD OF REPOSITIONING IT DURING THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502159 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7072758 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention