BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 14507851 · Received May 26, 2022

    Report

    Report Number
    3004209178-2022-06783
    Event Type
    Injury
    Date Received
    May 26, 2022
    Report Date
    May 25, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A PATIENT VIA MANUFACTURER REPRESENTATIVE WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THEY WILL BE REPLACING THE INS PROBABLY TO NON RECHARGEABLE INS SINCE THE PATIENT WANTS THE INS LOCATION CHANGED B/C WHEN SHE SITS IN HER CHURCH PEW THE INS LOCATION IS PAINFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1745431 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention