BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 11521837 · Received March 18, 2021

    Report

    Report Number
    3006630150-2021-01090
    Event Type
    Injury
    Date Received
    March 18, 2021
    Date of Event
    February 18, 2021
    Report Date
    April 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
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 7070084. LEAD SC-2317-70 SERIAL NUMBER (B)(6) THAT HAD MIGRATED OUT OF THE EPIDURAL SPACE AND WAS ENTANGLED WITH THE OTHER LEAD WAS DISPOSED OF AND WAS NOT RETURNED FOR ANALYSIS. LEAD MIGRATION WHICH WAS IDENTIFIED BY THE MEDICAL PROFESSIONAL IN THE FIELD, IS A KNOWN INHERENT RISK ASSOCIATED WITH USE OF THE DEVICE. PRODUCT LABELING STATES THAT LEAD MIGRATION RESULTING IN UNDESIRABLE CHANGES IN STIMULATION AND SUBSEQUENT REDUCTION IN PAIN RELIEF, IS ONE OF THE POSSIBLE RISKS OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION. RETURNED LEAD SC-2317-70 SERIAL NUMBER (B)(6) , WHICH WAS REMOVED AFTER THE PHYSICIAN NOTED THAT IT WAS DAMAGED JUST UNDER THE Y-BIFURCATION. THE LEAD WAS CLEANLY CUT AND THE DISTAL END WAS NOT RETURNED. THE LEAD DAMAGE NEAR THE Y-BIFURCATION MOST LIKELY WAS INTRODUCED WHEN THE LEAD MIGRATED. X-RAY INSPECTION FOUND NO CABLE FRACTURES. IT APPEARS THAT EXCESSIVE MECHANICAL FORCE WAS EXERTED ONTO THE LEAD BODY. THE LEAD WAS PULLED AND ALL CABLES WERE EXPOSED UNDER THE Y-BIFURCATION. THE LEAD DAMAGE NEAR THE Y-BIFURCATION MOST LIKELY WAS INTRODUCED DURING THE EXPLANT PROCEDURE. DAMAGE TO THE LEAD IS A RESULT OF A TYPICAL EXPLANT PROCEDURE. THE LEADS WERE FOUND TO BE ENTANGLED IN THE POCKET SITE. A PRODUCT LABELING REVIEW IDENTIFIED THAT BOTH LEADS WERE USED PER THE INSTRUCTIONS FOR USE PRODUCT LABEL. ADDITIONALLY, LEAD MIGRATION IS NOTED WITHIN THE IFU AS A POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THE DEVICE, WHICH CAN RESULT IN UNDESIRABLE CHANGES IN STIMULATION AND SUBSEQUENT REDUCTION IN PAIN RELIEF. BASED ON ALL AVAILABLE INFORMATION, ENGINEERS CONCLUDED THAT THE REPORTED EVENT OF INADEQUATE STIMULATION, HIGH IMPEDANCES, AND LEAD DAMAGE WAS MOST LIKELY CAUSED BY LEAD MIGRATION, WHICH IS A KNOWN INHERENT RISK ASSOCIATED WITH USE OF THE DEVICE. BOTH LEADS WERE FOUND ENTANGLED IN THE POCKET SITE BY THE PHYSICIAN DURING THE EXPLANT PROCEDURE. HOWEVER, THE LEAD SC-2317-70 SERIAL NUMBER (B)(6) THAT HAD MIGRATED OUT OF THE EPIDURAL SPACE WAS NOT RETURNED FOR ANALYSIS. AS SUCH, PHYSICAL ANALYSIS COULD NOT BEEN CONDUCTED IN OUR LABORATORY. PRODUCT RECORD REVIEW REVEALED NO DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, TECHNICIANS CONFIRMED THROUGH TECHNICAL ANALYSIS ON THE RETURNED LEAD SC-2317-70 SERIAL NUMBER (B)(6) THAT THE LEAD WAS DAMAGED AND ALL CABLES WERE EXPOSED UNDER THE Y-BIFURCATION. A LABELLING REVIEW FOUND THAT THE REPORTED EVENT IS A KNOWN RISK OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION. THEREFORE, DEVICE MIGRATION WAS THE MOST LIKELY CAUSE OF THE REPORTED EVENT OF INADEQUATE STIMULATION AND HIGH IMPEDANCES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD ONE LEAD THAT MIGRATED PARTLY OUT OF THE EPIDURAL SPACE. THE UPPER SIX LEAD CONTACTS WERE USED FOR CONTOUR, BUT IT DID NOT PROVIDE ADEQUATE STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE LEADS WERE FOUND TO BE ENTANGLED IN THE POCKET SITE. THE PHYSICIAN ASSESSED THAT THE LEAD THAT HAD NOT MIGRATED WAS VERY DAMAGED JUST UNDER THE Y-BIFURCATION. THE PHYSICIAN NOTED THAT THE DAMAGE ON THE LEAD MAY HAVE BEEN CAUSED DURING THE UNTANGLING OF THE LEADS. THE TWO LEADS WERE EXPLANTED AND REPLACED. THE PATIENT HAD POST-SURGICAL PAIN, BUT WAS ABLE TO REGAIN COVERAGE OF THE PAIN AREA IN THE LOWER BACK. THE SERIAL NUMBER OF THE SECOND LEAD IS UNKNOWN AND NO FURTHER INFORMATION COULD BE OBTAINED FOR THIS PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED THAT ONLY ONE LEAD WAS RETURNED, THE OTHER LEAD WAS DISCARDED BY THE FACILITY. THE PATIENT HAD POST-SURGICAL PAIN, BUT WAS ABLE TO REGAIN COVERAGE OF THE PAIN AREA IN THE LOWER BACK AREA.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2317-70, SERIAL: UNKNOWN, BATCH: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD ONE LEAD THAT MIGRATED PARTLY OUT OF THE EPIDURAL SPACE. THE UPPER SIX LEAD CONTACTS WERE USED FOR CONTOUR, BUT IT DID NOT PROVIDE ADEQUATE STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE LEADS WERE FOUND TO BE ENTANGLED IN THE POCKET SITE. THE PHYSICIAN ASSESSED THAT THE LEAD THAT HAD NOT MIGRATED WAS FRACTURED JUST BELOW THE Y-SECTION. THE PHYSICIAN HAD TO CUT THE LEAD IN ORDER TO EXPLANT IT. THE PHYSICIAN NOTED THAT THE DAMAGE ON THE LEAD MAY HAVE BEEN CAUSED DURING THE UNTANGLING OF THE LEADS. THERE WERE NO ISSUES WITH THE SECOND LEAD EXCEPT FOR MIGRATION. THE TWO LEADS WERE EXPLANTED AND REPLACED. THE PATIENT HAD POST-SURGICAL PAIN, BUT WAS ABLE TO REGAIN COVERAGE OF THE PAIN AREA IN THE LOWER BACK. THE SERIAL NUMBER OF THE SECOND LEAD IS UNKNOWN BECAUSE THE HOSPITAL HAD ONLY REGISTERED ONE LEAD. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417830 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 5179106 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention