BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION NOVI

    MDR report key: 20073854 · Received August 27, 2024

    Report

    Report Number
    3006630150-2024-05625
    Event Type
    Injury
    Date Received
    August 27, 2024
    Date of Event
    August 5, 2024
    Report Date
    September 20, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729897835
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT WAS CREATED AS NEW INFORMATION WAS RECEIVED AND ADDED TO B5 DESCRIBE EVENT OR PROBLEM, IT WAS REPORTED THAT 2 PERCUTANEOUS LEADS THAT HAD MOVED AND THIS DEVICE WAS EXPLANTED AT THE SURGEON'S DISCRETION. PRODUCT FAMILY: SCS-IPG-PC. UPN: M365SC11400. MODEL: SC-1140. SERIAL: (B)(6). BATCH: 203819. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7101783. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7101766.

    Additional Manufacturer Narrative · 0

    PRODUCT FAMILY: SCS-IPG-PC, UPN: M365SC11400, MODEL: SC-1140, SERIAL: (B)(6), BATCH: 203819. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7101783. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7101766.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) SYSTEM WAS REPLACED DUE TO PATIENT HAD TWO PERCUTANEOUS LEADS THAT MIGRATED. A COVERAGE PADDLE WAS IMPLANTED TO REPLACE THE LEADS AND THIS IMPLANTABLE PULSE GENERATOR (IPG) WAS ELECTIVELY REMOVED DURING THE PROCEDURE. THE PATIENT IS DOING WELL POST OPERATIVELY AND THE LOCATION OF DEVICE IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) SYSTEM WAS REPLACED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28391 PRECISION NOVI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1140 203819 08714729897835

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention