BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 10934912 · Received December 2, 2020

    Report

    Report Number
    3006630150-2020-05964
    Event Type
    Injury
    Date Received
    December 2, 2020
    Date of Event
    November 12, 2020
    Report Date
    December 2, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: (B)(4), MODEL: SC-8116-70, SERIAL: (B)(4), BATCH: 112928.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. THE EXPLANTED IPG AND PADDLE LEAD WILL NOT BE RETURNED. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1401011 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 701923

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention