BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 11665946 · Received April 14, 2021

    Report

    Report Number
    3006630150-2021-01558
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    March 19, 2021
    Report Date
    June 29, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BASED ON ALL AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE EVENT OF HIGH IMPEDANCES WAS A RESULT OF LEAD FRACTURE. DEVICE TECHNICAL ANALYSIS: ANALYSIS OF RETURNED LEAD SC-2317-70 (7073434) REVEALED THAT MULTIPLE CABLES WERE COMPLETELY BROKEN AT THE BENT LOCATION OF THE LEAD. THE BENT LOCATION IS 1 CM FROM THE SET SCREW MARK OF THE CLIK ANCHOR. THERE ARE NO EXPOSED CABLES AT THE FRACTURE LOCATION. THE LEAD WAS EXPOSED TO EXCESSIVE MECHANICAL FORCE OR MOVEMENT CAUSING THE CABLE FRACTURES RIGHT AT THE ANCHOR POINT. ANALYSIS OF RETURNED LEAD SC-2352-50 (7071718) REVEALED THAT THE LEAD DISTAL ARRAY IS SEPARATED BETWEEN ELECTRODE # 5 AND 6. IT APPEARS THAT EXCESSIVE MECHANICAL FORCE WAS EXERTED ONTO THE LEAD DISTAL ARRAY, RESULTING IN THE FRACTURE BETWEEN ELECTRODE # 5 AND 6. INVESTIGATION CONCLUSION: BASED ON ALL AVAILABLE INFORMATION, ENGINEERS CONCLUDED THAT THE HIGH IMPEDANCE MEASUREMENTS WERE CAUSED BY LEAD FRACTURE. THE LEADS WERE SUBJECTED TO EXCESSIVE MECHANICAL FORCE WHICH RESULTED IN THE LEAD FRACTURES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH THREE LEADS: ONE FOR BACK PAIN AND TWO SACRAL LEADS FOR INCONTINENCE. THE PATIENT EXPERIENCED PAIN AND CRAMPS IN THE LEG. HIGH IMPEDANCES WERE OBSERVED ON THE LEAD FOR BACK PAIN AND ONE OF THE SACRAL LEADS. X-RAYS SHOWED THAT THE HIGH IMPEDANCE SACRAL LEAD HAD FLIPPED BACK OUT OF THE ORIGINAL POSITION. THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE THE TWO HIGH IMPEDANCE LEADS. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2352-50, SERIAL: (B)(4), BATCH: 7071729. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2352-50, SERIAL:(B)(4), BATCH: 7071718. PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: (B)(4), MODEL: SC-4318, SERIAL: N/A, BATCH: 25906222.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH THREE LEADS: ONE FOR BACK PAIN AND TWO SACRAL LEADS FOR INCONTINENCE. THE PATIENT EXPERIENCED PAIN AND CRAMPS IN THE LEG. HIGH IMPEDANCES WERE OBSERVED ON THE LEAD FOR BACK PAIN AND ONE OF THE SACRAL LEADS. X-RAYS SHOWED THAT THE HIGH IMPEDANCE SACRAL LEAD HAD FLIPPED BACK OUT OF THE ORIGINAL POSITION. THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE THE TWO HIGH IMPEDANCE LEADS. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565487 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7073434 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention