BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPLANTABLE PULSE GENERATOR

    MDR report key: 18191752 · Received November 21, 2023

    Report

    Report Number
    MW5148360
    Event Type
    Other
    Date Received
    November 21, 2023
    Report Date
    November 21, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLED AND STATED SHE RECEIVED A URGENT MEDICAL DEVICE CORRECTION LETTER FOR IMPLANTABLE PULSE GENERATOR IN (B)(6) 2023. NO MODEL NUMBER, SERIAL NUMBER OR LOT NUMBER WAS PROVIDED. NO ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223139 IMPLANTABLE PULSE GENERATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Female