BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 10512212 · Received September 9, 2020

    Report

    Report Number
    3006630150-2020-04083
    Event Type
    Injury
    Date Received
    September 9, 2020
    Date of Event
    March 10, 2020
    Report Date
    September 9, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: (B)(4). MODEL: SC-2316-70. SERIAL: (B)(4). BATCH: 2000022862. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: (B)(4). MODEL: SC-2316-70. SERIAL: (B)(4). BATCH: 2000022862. PRODUCT FAMILY: SCS-SPLITTERS. UPN: (B)(4). MODEL: SC-3400-30. SERIAL: (B)(4). BATCH: 2000018996. PRODUCT FAMILY: SCS-SPLITTERS. UPN: (B)(4). MODEL: SC-3400-30. SERIAL: (B)(4). BATCH: 2000019102. DEVICE TECHNICAL ANALYSIS: THE RETURNED INFINION CX LEAD MODEL SC-2316-70 SERIAL NUMBER 3208968 WAS ANALYZED, AND VISUAL AND X-RAY INSPECTION REVEALED 12 FRACTURED CABLES AT THE CLIK SITE. THE LEAD GOT KINKED AFTER IT EXITS THE CLIK ANCHOR RESULTING IN THE REPORTED COMPLAINT. IT APPEARS THAT EXCESSIVE MECHANICAL/TENSILE FORCE WAS EXERTED ONTO THE LEAD, RESULTING IN THE CABLE FRACTURES. THE RETURNED INFINION LEAD MODEL SC-2316-70 SERIAL NUMBER 3210701 WAS ANALYZED, AND VISUAL AND X-RAY INSPECTION REVEALED THE LEAD BODY WAS CLEANLY CUT DURING THE EXPLANT PROCEDURE AND FOUND NO OTHER CABLE DAMAGE EXCEPT THE INTENTIONAL CUT. THE CLEAN CUT DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE. THE RETURNED SPLITTER MODEL SC-3400-30 SERIAL NUMBER 609725 WAS ANALYZED, AND VISUAL AND X-RAY INSPECTION REVEALED LEAD BODY WAS CLEANLY CUT DURING THE EXPLANT PROCEDURE AND FOUND NO OTHER CABLE DAMAGE EXCEPT INTENTIONAL CUT. THE CLEAN CUT DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE. THE RETURNED SPLITTER MODEL SC-3400-30 SERIAL NUMBER 579386 WAS ANALYZED, AND VISUAL AND X-RAY INSPECTION REVEALED LEAD BODY WAS CLEANLY CUT DURING THE EXPLANT PROCEDURE AND FOUND NO OTHER CABLE DAMAGE EXCEPT INTENTIONAL CUT. THE CLEAN CUT DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE. INVESTIGATION CONCLUSION: THE INVESTIGATION CONCLUDED THAT THE REPORTED EVENT OF HIGH IMPEDANCES AND LOSS OF STIMULATION WAS CONFIRMED THROUGH DEVICE ANALYSIS. THEREFORE, THE MOST PROBABLE CAUSE WAS TRACED TO COMPONENT FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A LOSS OF PAIN COVERAGE. AT A REPROGRAMMING SESSION IT SHOWED THERE WERE HIGH IMPEDANCES ON HALF OF THE CONTACTS. THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE THE LEADS AND SPLITTERS. THE PATIENT WAS RECEIVING GOOD PAIN COVERAGE AND DOING WELL POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970615 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 2000022063 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention