BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCS IPG

    MDR report key: 15135208 · Received July 29, 2022

    Report

    Report Number
    1627487-2022-04180
    Event Type
    Malfunction
    Date Received
    July 29, 2022
    Report Date
    September 15, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SPECIFIC PATIENT AND PRODUCT INFORMATION IS UNABLE TO BE OBTAINED.

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE DEVICE AND EVENT INFORMATION.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-04179. IT WAS REPORTED TO THE FDA IN A PMA SUPPLEMENT (P010032/S189) FOR AN INDICATION EXPANSION FOR DIABETIC PERIPHERAL NEUROPATHY PAIN. THE STUDY TO EVALUATE THE SAFETY OF SPINAL CORD STIMULATION (SCS) FOR PATIENTS WITH DIABETIC PERIPHERAL NEUROPATHY USING REAL-WORLD EVIDENCE METHODS THAT ABBOTT LEADS AND IPGS MAY BE RELATED TO ADVERSE EVENTS OR MALFUNCTIONS. SPECIFIC PATIENT INFORMATION AND PRODUCT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE STUDY, TITLED DIABETIC PERIPHERAL NEUROPATHY SPINAL CORD STIMULATION REAL-WORLD EVIDENCE STUDY PROTOCOL AND REPORT. A REVIEW OF THIS DATA FOR THE DATE RANGE OF 2014-2020 SHOWED APPROXIMATELY 10,201 NUMBER OF ADVERSE EVENTS (RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-04179) THAT OCCURRED AFTER A SCS PROCEDURE WHICH MAY OR MAY NOT BE ASSOCIATED WITH THE PRODUCT OR PROCEDURE. ALSO, APPROXIMATELY 9,906 NUMBER OF MALFUNCTIONS WERE REPORTED AFTER A SCS PROCEDURE WHICH MAY OR MAY NOT BE ASSOCIATED WITH THE PRODUCT OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2316648 SCS IPG SCS IPG LGW ABBOTT MEDICAL NMD0015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown