BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 10776054 · Received November 2, 2020

    Report

    Report Number
    3006630150-2020-05297
    Event Type
    Injury
    Date Received
    November 2, 2020
    Date of Event
    July 1, 2020
    Report Date
    December 17, 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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE TECHNICAL ANALYSIS: VISUAL MICROSCOPE AND X-RAY INSPECTION OF THE LEAD SC-2317-70 SERIAL NUMBER (B)(6) REVEALED THAT MULTIPLE CABLES WERE COMPLETELY BROKEN 2 CM FROM THE SET SCREW MARK OF THE CLIK X ANCHOR AT THE BENT-KINKED LOCATION OF THE LEAD. THERE WERE NO EXPOSED CABLES AT THE CLIK X ANCHOR SITE FRACTURE LOCATION. THE LEAD GETS KINKED AFTER IT EXITS THE CLIK X ANCHOR RESULTING IN THE REPORTED COMPLAINT. LEAD SC-2317-70 SERIAL NUMBER (B)(6) WAS NOT RETURNED FOR ANALYSIS. DEVICE HISTORY RECORD REVIEW: A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS SC-2317-70 SERIAL NUMBER (B)(6) REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVEN OCCURRED DURING MANUFACTURING. INVESTIGATION CONCLUSION: THE COMPLAINT OF HIGH IMPEDANCES WAS CONFIRMED THROUGH PRODUCT ANALYSIS OF SC-2317-70 SERIAL NUMBER (B)(6). THE PROBABLE CAUSE HAS BEEN TRACED TO COMPONENT FAILURE.

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT: (B)(6) 2020. H6 PATIENT CODE 3191: NO CODE AVAILABLE WAS USED BECAUSE THERE IS NOT AN EQUIVALENT FDA CODE FOR SURGICAL INTERVENTION. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 7070247.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STAB-LIKE, BURNING PAIN AND ELECTRIC SHOCKS AFTER SEVERAL FALLS. UPON ASSESSING THE ISSUE, IT WAS FOUND THAT THERE WERE HIGH IMPEDANCES ON THE LEAD AND DIFFICULTIES WERE ENCOUNTERED WITH PROGRAMMING THE DEVICE TO COVER THE TARGETED PAIN AREAS. PATIENT WAS PRESCRIBED STRONG OPIOIDS AND THEN UNDERWENT A REVISION PROCEDURE. DURING THE PROCEDURE A SMALL DURA MATER BREACH OCCURRED; HOWEVER, POST-OPERATIVE RESULTS WERE GOOD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STAB-LIKE, BURNING PAIN AND ELECTRIC SHOCKS AFTER SEVERAL FALLS. UPON ASSESSING THE ISSUE, IT WAS FOUND THAT THERE WERE HIGH IMPEDANCES ON THE LEAD AND DIFFICULTIES WERE ENCOUNTERED WITH PROGRAMMING THE DEVICE TO COVER THE TARGETED PAIN AREAS. PATIENT WAS PRESCRIBED STRONG OPIOIDS AND THEN UNDERWENT A REVISION PROCEDURE. DURING THE PROCEDURE A SMALL DURA MATER BREACH OCCURRED; HOWEVER, POST-OPERATIVE RESULTS WERE GOOD.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2020. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STAB-LIKE, BURNING PAIN AND ELECTRIC SHOCKS AFTER SEVERAL FALLS. UPON ASSESSING THE ISSUE, IT WAS FOUND THAT THERE WERE HIGH IMPEDANCES ON THE LEAD AND DIFFICULTIES WERE ENCOUNTERED WITH PROGRAMMING THE DEVICE TO COVER THE TARGETED PAIN AREAS. PATIENT WAS PRESCRIBED STRONG OPIOIDS AND THEN UNDERWENT A REVISION PROCEDURE. DURING THE PROCEDURE A SMALL DURA MATER BREACH OCCURRED; HOWEVER, POST-OPERATIVE RESULTS WERE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240170 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 5101499 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention