BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION NOVI

    MDR report key: 10082716 · Received May 22, 2020

    Report

    Report Number
    3006630150-2020-02167
    Event Type
    Injury
    Date Received
    May 22, 2020
    Date of Event
    May 4, 2020
    Report Date
    June 8, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729897835
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR REVISION WAS DUE TO LEAD MIGRATION. THE PHYSICIAN OPTED TO REMOVED AND UPGRADE THE IPG FOR BEST POSSIBLE OUTCOME. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND WAS GETTING BETTER COVERAGE. THE EXPLANTED DEVICES WERE DISCARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEADS REPLACED FOR AN UNKNOWN REASON.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/ CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/ LOT NUMBER: 5123587/ 5123637, MODEL/ CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEADS REPLACED FOR AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546900 PRECISION NOVI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1140 21509900 08714729897835

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention