BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 10695562 · Received October 19, 2020

    Report

    Report Number
    3006630150-2020-04929
    Event Type
    Injury
    Date Received
    October 19, 2020
    Date of Event
    October 6, 2020
    Report Date
    December 14, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H6 PATIENT CODE 3191: NO CODE AVAILABLE WAS USED BECAUSE THERE IS NOT AN EQUIVALENT FDA CODE FOR SURGICAL INTERVENTION. THE IPG WAS NOT RETURNED FOR ANALYSIS AND THE COMPLAINT OF DIFFICULTY CHARGING COULD NOT BE CONFIRMED. RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. THE INVESTIGATION IS UNABLE TO DETERMINE A PROBABLE CAUSE FOR THE CHARGING ISSUES; THEREFORE, THE CAUSE CANNOT BE ESTABLISHED. ANALYSIS OF PHOTOS PROVIDED BY THE REP OF THE LEADS SC-248-74 SERIAL NUMBER (B)(6) AND (B)(6) CONFIRMED THAT THE LEAD BODY WAS FRAYED A FEW CENTIMETERS FROM THE LEAD PROXIMAL ARRAY. IT WAS REPORTED BY REP THAT THERE WERE NO IMPEDANCE ANOMALIES POST IMPLANT OR PRE-EXPLANT. ALL AVAILABLE INFORMATION SUGGESTS THAT THE DAMAGE TO THE LEAD OCCURRED DURING THE EXPLANT PROCEDURE. IT APPEARS THAT LEAD BODY INSULATION AND ITS INTERNAL CABLES WERE COMPROMISED DURING THE PROCEDURE. IT IS POSSIBLE THAT THE LEAD BODY WAS NICKED BY A SURGICAL TOOL. ONCE THE LEAD BODY INSULATION IS COMPROMISED, THE COILED CABLES WITHIN IT WILL BE UNDONE AND WOULD APPEAR STRETCHED WHEN PULLED. THE COMPLAINT OF LEAD BODY DAMAGE WAS CONFIRMED THOUGH ANALYSIS OF PRODUCT PICTURES. THE PROBABLE CAUSE WAS TRACED TO UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY CHARGING HER IPG AFTER BEING IMPLANTED FOR TWO MONTHS. UPON INSPECTION OF THE IPG POCKET SITE, THE DEVICE COULD BE FELT FROM THE SKIN; AND AFTER TRYING 2 SEPARATE CHARGING SYSTEMS THEY WERE NOT SUCCESSFUL IN CHARGING THE IMPLANTED BATTERY. PHYSICIAN DECIDED TO DO A REVISION PROCEDURE TO INSPECT THE IPG AND ENSURE THAT IT WAS PLACED CORRECTLY. AS THE PHYSICIAN WAS UNEARTHING THE IPG HE NOTICED THAT THE DISTAL ENDS OF THE LEADS HAD BECOME SO BADLY FRAYED THAT THEY HAD ALMOST COMPLETELY FRACTURED. AT THAT TIME THE DECISION WAS MADE TO REPLACE THE ENTIRE SCS SYSTEM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI. UPN: (B)(4). MODEL: SC-2408-74. SERIAL: 7070798. BATCH: 7070798. PRODUCT FAMILY: SCS-LINEAR LEADS-MRI. UPN: (B)(4). MODEL: SC-2408-74. SERIAL: 7070841. BATCH: 7070841.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY CHARGING HER IPG AFTER BEING IMPLANTED FOR TWO MONTHS. UPON INSPECTION OF THE IPG POCKET SITE, THE DEVICE COULD BE FELT FROM THE SKIN; AND AFTER TRYING 2 SEPARATE CHARGING SYSTEMS THEY WERE NOT SUCCESSFUL IN CHARGING THE IMPLANTED BATTERY. PHYSICIAN DECIDED TO DO A REVISION PROCEDURE TO INSPECT THE IPG AND ENSURE THAT IT WAS PLACED CORRECTLY. AS THEY PHYSICIAN WAS UNEARTHING THE IPG HE NOTICED THAT THE DISTAL ENDS OF THE LEADS HAD BECOME SO BADLY FRAYED THAT THEY HAD ALMOST COMPLETELY FRACTURED. AT THAT TIME THE DECISION WAS MADE TO REPLACE THE ENTIRE SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166025 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 368359 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention