BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 20081342 · Received August 27, 2024

    Report

    Report Number
    3006630150-2024-05654
    Event Type
    Injury
    Date Received
    August 27, 2024
    Date of Event
    August 13, 2022
    Report Date
    December 2, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN 2022. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(6), BATCH: 5067220. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(6), BATCH: 21644253. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 21584987. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 5072124.

    Additional Manufacturer Narrative · 0

    DEVICE ANALYSIS PERFORMED ON THE RETURNED IPG REVEALED NORMAL DEVICE CHARACTERISTICS DURING A DATA LOG ANALYSIS AND VISUAL AND FUNCTIONAL TESTING. A PRODUCT LABELING REVIEW THAT WAS CONDUCTED DETERMINED THAT LEAD BREAKAGE, LOOSE CONNECTIONS AND ELECTRICAL ISSUES CAN RESULT IN REDUCTION IN PAIN RELIEF AND IS A KNOWN RISK OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION, AS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU). BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN 2022. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2352700. MODEL: SC-2352-70. SERIAL: (B)(6). BATCH: 5067220. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2352700. MODEL: SC-2352-70. SERIAL: (B)(6). BATCH: 21644253. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2366500. MODEL: SC-2366-50. SERIAL: (B)(6). BATCH: 21584987. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2366500. MODEL: SC-2366-50. SERIAL: (B)(6). BATCH: 5072124.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT AN EXPLANT PROCEDURE DURING WHICH THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS WERE REMOVED DUE TO INADEQUATE PAIN RELIEF. THERE WERE NO REPORTED PATIENT COMPLICATIONS POSTOPERATIVELY. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT AN EXPLANT PROCEDURE DURING WHICH THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS WERE REMOVED DUE TO INADEQUATE PAIN RELIEF. THERE WERE NO REPORTED PATIENT COMPLICATIONS POSTOPERATIVELY. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158346 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1132 203509 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention