BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA MRI

    MDR report key: 9335138 · Received November 18, 2019

    Report

    Report Number
    3006630150-2019-06584
    Event Type
    Injury
    Date Received
    November 18, 2019
    Date of Event
    November 4, 2019
    Report Date
    February 10, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729904816
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FIELD D7 - DATE OF EXPLANT - (B)(6) 2019. FIELD D7 - DATE OF ADDITIONAL SURGERY TO REMOVE PIECE OF LEAD THAT WAS LEFT INSIDE PATIENT - (B)(6) 2019. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT THE ADDITIONAL PROCEDURE ON 02DEC2020 AND WAS DOING WELL POST OPERATIVELY. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CORPORATION CONCLUDES THAT THE COMPLAINT HAS BEEN CONFIRMED FOR LEAD SC-2408-56 SERIAL 3140474. VISUAL INSPECTION FOUND LEAD INSULATION DAMAGE AND FRACTURED CABLES 15.5 CM FROM THE DISTAL END. THE DAMAGED SECTION OF THE LEAD BODY INSULATION SHOWS SIGNS OF ABRASION THAT EVENTUALLY OPENED UP, EXPOSED, AND DAMAGED THE CABLES WITHIN THE LEAD BODY. IT APPEARS THAT THE DAMAGED SECTION OF THE LEAD IS THE ANCHOR POINT OR WHERE THE LEAD WAS SECURED. ADDITIONALLY, MULTIPLE SECTIONS OF THE LEAD BODY ARE DEFORMED AND APPEARED WAVY. THIS DAMAGE SUGGESTS THAT THE LEAD BODY WAS STRETCHED CAUSING THE DEFORMATION OF THE LEAD INSULATION AND CABLES WITHIN THE INSULATION. THE LEAD WAS EXPOSED TO EXCESSIVE MECHANICAL FORCE OR MOVEMENT CAUSING DAMAGE TO THE LEAD BODY AND CABLE FRACTURES RIGHT AT THE ANCHOR POINT. IT IS UNKNOWN IF SUTURE SLEEVE, CLIK X MRI ANCHOR OR DIRECT SUTURE WERE USED TO SECURE THE LEAD.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT DEVICE. MODEL SC-2408-56. SERIAL (B)(4). BATCH 20323006. FLAGGED F/U AWARE DATE 20 NOV WE NOW HAVE IMPLANT DATE.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT ONE OF THE PATIENT'S LEAD DISPLAYED HIGH IMPEDANCES. IT IS NOT KNOWN WHICH LEAD HAD THE IMPEDANCES. THE PATIENT UNDERWENT A LEAD EXPLANT PROCEDURE AND DURING THE REMOVAL OF THE LEAD, A FRACTURE OF THE LEAD WAS NOTED, LEAVING A PART OF THE LEAD AT THE ENTRANCE OF THE EPIDURAL SPACE. THE PATIENT WILL UNDERGO ANOTHER SURGERY AT A LATER DATE TO REMOVE THE PIECE OF THE LEAD THAT WAS LEFT INSIDE THE PATIENT'S BODY.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT ONE OF THE PATIENT'S LEAD DISPLAYED HIGH IMPEDANCES. IT IS NOT KNOWN WHICH LEAD HAD THE IMPEDANCES. THE PATIENT UNDERWENT A LEAD EXPLANT PROCEDURE AND DURING THE REMOVAL OF THE LEAD, A FRACTURE OF THE LEAD WAS NOTED, LEAVING A PART OF THE LEAD AT THE ENTRANCE OF THE EPIDURAL SPACE. THE PATIENT WILL UNDERGO ANOTHER SURGERY AT A LATER DATE TO REMOVE THE PIECE OF THE LEAD THAT WAS LEFT INSIDE THE PATIENT'S BODY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT DEVICE: MODEL: SC-2408-56, SERIAL: (B)(4), BATCH: 20323006.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT ONE OF THE PATIENT'S LEAD DISPLAYED HIGH IMPEDANCES. IT IS NOT KNOWN WHICH LEAD HAD THE IMPEDANCES. THE PATIENT UNDERWENT A LEAD EXPLANT PROCEDURE AND DURING THE REMOVAL OF THE LEAD, A FRACTURE OF THE LEAD WAS NOTED, LEAVING A PART OF THE LEAD AT THE ENTRANCE OF THE EPIDURAL SPACE. THE PATIENT WILL UNDERGO ANOTHER SURGERY AT A LATER DATE TO REMOVE THE PIECE OF THE LEAD THAT WAS LEFT INSIDE THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133503 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-56 20323006 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention