BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM¿ 7 ELITE IMPLANTABLE PULSE GENERATOR

    MDR report key: 17868149 · Received October 4, 2023

    Report

    Report Number
    1627487-2023-04725
    Event Type
    Injury
    Date Received
    October 4, 2023
    Date of Event
    August 4, 2023
    Report Date
    October 4, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05415067031426
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE PATIENT INFORMATION. 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 INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    THE ALLEGATION IS AGAINST ONE OF FIVE LEADS; HOWEVER, IT IS UNKNOWN WHICH LEAD(S), THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS, MODEL: MN10450-50A, UDI: (B)(4) , SERIAL: (B)(6) , BATCH: 6821217. PRODUCT FAMILY: SCS, MODEL: MN10450-50A, UDI: (B)(4) , SERIAL: (B)(6), BATCH: 6853895. PRODUCT FAMILY: SCS, MODEL: MN10450-50A, UDI: (B)(4) , SERIAL: (B)(6), BATCH: 8041925. PRODUCT FAMILY: SCS, MODEL: 3186: (B)(4) , SERIAL: (B)(6), BATCH: A000108467. THE ALLEGATION IS AGAINST ONE OF TWO IPG'S; HOWEVER, IT IS UNKNOWN WHICH IPG(S), THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS, MODEL:3664, UDI: (B)(4) , SERIAL: (B)(6), BATCH: 7103242.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER. IT WAS REPORTED THE PATIENT EXPERIENCED PAIN AT THE POCKET SITE AND INEFFECTIVE STIMULATION. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE DRG AND SCS SYSTEMS PER EXPLANTED TO ADDRESS THE ISSUES. IT IS UNKNOWN WHICH LEADS OR IPG¿S ATTRIBUTED TO THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104536 PROCLAIM¿ 7 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG LGW ABBOTT MEDICAL 3662 8149785 05415067031426

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Other DRG IPG| DRG LEAD| DRG LEADS X 2| SCS ANCHOR| SCS LEAD