BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 16659725 · Received March 31, 2023

    Report

    Report Number
    3006630150-2023-01728
    Event Type
    Injury
    Date Received
    March 31, 2023
    Date of Event
    January 24, 2023
    Report Date
    May 5, 2023
    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
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MICROSCOPIC INSPECTION OF THE RETURNED SC-2317-50 SERIAL NUMBER (B)(6) REVEALED ALL CABLES WERE COMPLETELY BROKEN 2 CENTIMETERS (CM) FROM THE SET SCREW MARK OF THE CLIK X ANCHOR AT THE BENT/KINKED LOCATION OF THE LEAD; HOWEVER, THERE WERE NO EXPOSED CABLES AT THE FRACTURE LOCATION. THE LEAD GOT KINKED AFTER IT EXITED THE CLIK X ANCHOR, BUT IT APPEARS THE LEAD WAS EXPOSED TO EXCESSIVE MECHANICAL FORCE OR MOVEMENT CAUSING THE CABLES TO FRACTURE. X-RAY INSPECTION OF THE RETURNED SC-2317-50 SERIAL NUMBER (B)(6) REVEALED THE 12TH ELECTRODE OF THE DISTAL END HAD A FRACTURED CABLE AT THE WELD NUGGET; HOWEVER, THE CABLE WAS NOT EXPOSED. THIS TYPE OF DAMAGE TYPICALLY OCCURS WHEN EXCESSIVE TENSILE FORCE IS EXERTED ONTO THE LEAD BODY AND CONNECTOR SECTION OF THE LEAD. ANALYSIS OF THE RETURNED SC-1232 SERIAL NUMBER (B)(6) AND SC-4318 BATCH/LOT 29532517 REVEALED NO ANOMALIES. THE DEVICES DISPLAYED NORMAL DEVICE CHARACTERISTICS DURING VISUAL AND FUNCTION TESTING, WITH IMPEDANCES MEASUREMENTS ON THE IPG BEING WITHIN THE EXPECTED RANGE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R-MRI, UPN: M365SC12320, MODEL: SC-1232, SERIAL: (B)(4), BATCH: 553140. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 5152448. PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: M365SC43180, MODEL: SC-4318, SERIAL: NA, BATCH: 29532517.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF PAIN COVERAGE. THE PHYSICIAN ASSESSED THE PRESENCE OF HIGH IMPEDANCE READINGS ON THE LEADS. X-RAY IMAGING TAKEN IN THE FIELD CONFIRMED THE LEADS WERE INTACT. ATTEMPTS TO REPROGRAM THE DEVICE WERE UNSUCCESSFUL. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE SPINAL CORD STIMULATION (SCS) SYSTEM WAS REPLACED AND DID WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF PAIN COVERAGE. THE PHYSICIAN ASSESSED THE PRESENCE OF HIGH IMPEDANCE READINGS ON THE LEADS. X-RAY IMAGING TAKEN IN THE FIELD CONFIRMED THE LEADS WERE INTACT. ATTEMPTS TO REPROGRAM THE DEVICE WERE UNSUCCESSFUL. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE SPINAL CORD STIMULATION (SCS) SYSTEM WAS REPLACED AND DID WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1720467 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 7075779 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention