BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-4

    MDR report key: 18946201 · Received March 20, 2024

    Report

    Report Number
    3006630150-2024-01644
    Event Type
    Injury
    Date Received
    March 20, 2024
    Date of Event
    February 23, 2024
    Report Date
    June 17, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789581
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MODEL: SC-2408-74, SERIAL: (B)(6): DAMAGE TO THE LEAD IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IS NOT CONSIDERED A FAILURE. VISUAL INSPECTION REVEALED A PORTION OF THE LEAD WAS STUCK INSIDE PORT D OF THE IPG AND THERE WAS NO SET SCREW. X-RAY IMAGING REVEALED THIS LEAD APPEARED TO HAVE GOTTEN CAUGHT UPON REMOVAL DURING THE PROCEDURE AGAINST THE CONNECTOR BLOCK AND BECAME COMPRESSED DUE TO A DAMAGED CONTACT THAT BECAME MISSHAPEN. THIS PORTION OF LEAD WAS EXTREMELY WEDGED IN THE PORT AND UNABLE TO BE RETRIEVED WITHOUT FURTHER DESTROYING THE DEVICE. MODEL: SC-2352-70, SERIAL (B)(6): THE RETURNED LEAD WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. MODEL: SC-4319, LOT-BATCH: 25329557: THE CLIK ANCHOR WAS NOT RETURNED FOR ANALYSIS AS IT WAS DISCARDED BY THE MEDICAL FACILITY, THEREFORE, A PHYSICAL ANALYSIS HAS NOT BEEN CONDUCTED IN OUR LABORATORY. THERE WAS NO ALLEGATION AGAINST THIS DEVICE. MODEL: SC-4318, LOT-BATCH: 26368986: THE RETURNED CLIK ANCHOR WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THERE WAS NO ALLEGATION AGAINST THIS DEVICE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT BRAND NAME: AVISTA MRI UPN: M365SC2408740 MODEL: SC-2408-74 SERIAL: (B)(6). BATCH: 7071206 BRAND NAME: CLIK X MRI UPN: M365SC43190 MODEL: SC-4319 SERIAL: (B)(6). BATCH: 25329557 BRAND NAME: CLIK X UPN: M365SC43180 MODEL: SC-4318 SERIAL:(B)(6). BATCH: 26368986

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BOTH OF THE PATIENTS SPINAL CORD STIMULATION LEADS MIGRATED BY APPROXIMATELY FOUR CONTACTS TO CAUDAL. THE PATIENT DID NOT EXPERIENCE ANY STIMULATION DUE TO THE MIGRATION. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE IN WHICH BOTH LEADS AND CLIK ANCHORS WERE REPLACED. THE TWO LEADS AND ONE OF THE CLIK ANCHORS WILL BE RETURNED. THE SECOND CLIK ANCHOR WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY. THE PATIENT WAS DOING FINE POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BOTH OF THE PATIENTS SPINAL CORD STIMULATION LEADS MIGRATED BY APPROXIMATELY FOUR CONTACTS TO CAUDAL. THE PATIENT DID NOT EXPERIENCE ANY STIMULATION DUE TO THE MIGRATION. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE IN WHICH BOTH LEADS AND CLIK ANCHORS WERE REPLACED. THE TWO LEADS AND ONE OF THE CLIK ANCHORS WILL BE RETURNED. THE SECOND CLIK ANCHOR WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY. THE PATIENT WAS DOING FINE POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893341 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-70 7071607 08714729789581

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention