BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM¿ DRG IMPLANTABLE PULSE GENERATOR

    MDR report key: 19035780 · Received April 3, 2024

    Report

    Report Number
    1627487-2024-07637
    Event Type
    Injury
    Date Received
    April 3, 2024
    Date of Event
    March 11, 2024
    Report Date
    April 17, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067020215
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SLIM TIP LEAD, MODEL: MN20450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 9242372. COMMON DEVICE NAME: SLIM TIP LEAD, MODEL: MN20450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 9242372.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED WHEREIN THE SCS SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-07638. IT WAS REPORTED THE PATIENT EXPERIENCED PAIN AT THE IPG SITE AND INEFFECTIVE STIMULATION. SURGICAL INTERVENTION MAY OCCUR LATER TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1545006 PROCLAIM¿ DRG IMPLANTABLE PULSE GENERATOR DRG IPG PMP ABBOTT MEDICAL 3664 T00005575 05415067020215

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Other DRG LEADX2