BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM¿ DRG IMPLANTABLE PULSE GENERATOR

    MDR report key: 20062994 · Received August 26, 2024

    Report

    Report Number
    1627487-2024-10617
    Event Type
    Injury
    Date Received
    August 26, 2024
    Date of Event
    February 6, 2024
    Report Date
    October 28, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067020215
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT ESTIMATED. THE ALLEGATION IS AGAINST [1] OF [2] [LEAD]; HOWEVER, IT IS UNKNOWN WHICH [LEAD(S)], THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 9042817.

    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 INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE COULD NOT DELIVER THE DESIRED STRENGTH. UPON FURTHER INVESTIGATION THE SYSTEM DIAGNOSTICS RECORDED HIGH IMPEDANCES ON THE LEAD AND THAT THE LEAD HAD MIGRATED, WHICH WAS CONFIRMED VIA X-RAY. AS A RESULT, THE PATIENT IS EXPERIENCING INEFFECTIVE STIMULATION. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT WAS EXPERIENCING SHOCKING AT THE IPG SITE. SURGICAL INTERVENTION TOOK PLACE WHERE THE IPG AND LEAD WERE EXPIATED AND REPLACED TO ADDRESS THE ISSUE. EFFECTIVE STIMULATION WAS RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276330 PROCLAIM¿ DRG IMPLANTABLE PULSE GENERATOR DRG IPG PMP ABBOTT MEDICAL 3664 T00005525 05415067020215

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SCS LEAD.