BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 14794735 · Received June 23, 2022

    Report

    Report Number
    3006630150-2022-03083
    Event Type
    Injury
    Date Received
    June 23, 2022
    Date of Event
    May 27, 2022
    Report Date
    August 2, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    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

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R; UPN: M365SC11600; MODEL: SC-1160; SERIAL: (B)(4); BATCH: 377364. PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2366500; MODEL: SC-2366-50; SERIAL: (B)(4); BATCH: 16327976. PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2366500; MODEL: SC-2366-50; SERIAL: (B)(4); BATCH: 16398198. PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2366500; MODEL: SC-2366-50; SERIAL: (B)(4); BATCH: 16399166. PRODUCT FAMILY: SCS-EXTENSION; UPN: M365SC3138550; MODEL: SC-3138-50; SERIAL: (B)(4); BATCH: 16097639. PRODUCT FAMILY: SCS-EXTENSION; UPN: M365SC3138550; MODEL: SC-3138-50; SERIAL: (B)(4); BATCH: 16130539.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138250, MODEL: SC-3138-25, SERIAL: (B)(6), BATCH: 7023524. PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138250, MODEL: SC-3138-25, SERIAL: (B)(6), BATCH: 7070376. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(6), BATCH: 5058302. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 5072649. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7025917. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 1001944. PRODUCT FAMILY: SCS-SPLITTERS, UPN: M365SC3354250, MODEL: SC-3354-25, SERIAL: (B)(6), BATCH: 673172. PRODUCT FAMILY: SCS-SPLITTERS, UPN: M365SC3354250, MODEL: SC-3354-25, SERIAL: (B)(6), BATCH: 673192. PRODUCT FAMILY: SCS-SPLITTERSM UPN: M365SC3354250, MODEL: SC-3354-25, SERIAL: (B)(6), BATCH: 694830. PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138250, MODEL: SC-3138-25, SERIAL: (B)(6), BATCH: 7070756. PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138250, MODEL: SC-3138-25, SERIAL: (B)(6), BATCH: 7070883. PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138250, MODEL: SC-3138-25, SERIAL: (B)(6), BATCH: 7074842. PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138250, MODEL: SC-3138-25, SERIAL: (B)(6), BATCH: 7076507.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT FEELS AS THOUGH SHE WAS NOT RECEIVING ENOUGH BENEFIT FROM THE DEVICE. THE PATIENT UNDERWENT A REVISION PROCEDURE AND TWO IMPLANTABLE PULSE GENERATORS (IPGS), ALL LEADS, AND ALL SPLITTERS WERE EXPLANTED. ALL EXPLANTED PRODUCTS WERE DISPOSED OF BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT FEELS AS THOUGH SHE WAS NOT RECEIVING ENOUGH BENEFIT FROM THE DEVICE. THE PATIENT UNDERWENT A REVISION PROCEDURE AND TWO IMPLANTABLE PULSE GENERATORS (IPGS), ALL LEADS, AND ALL SPLITTERS WERE EXPLANTED. ALL EXPLANTED PRODUCTS WERE DISPOSED OF BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328767 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 16479943 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention