BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM¿ DRG IMPLANTABLE PULSE GENERATOR

    MDR report key: 19348076 · Received May 18, 2024

    Report

    Report Number
    1627487-2024-08770
    Event Type
    Injury
    Date Received
    May 18, 2024
    Date of Event
    April 25, 2024
    Report Date
    June 13, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067020215
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT ESTIMATED. THE ALLEGATION IS AGAINST 1 OF 2 LEADS; HOWEVER, IT IS UNKNOWN WHICH LEAD, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: DRG SLIM TIP LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8904026.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, A SINGLE DEFINITIVE ROOT CAUSE FOR THE ISSUE ENCOUNTERED WAS UNABLE TO BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY DUE TO THE PATIENT LEAD MIGRATING WITH WAS CONFIRMED VIA IMAGING, AND AS A RESULT THE PATIENT HAD INEFFECTIVE THERAPY. SURGICAL INTERVENTION TOOK PLACE (B)(6) 2024 WHERE THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. DURING THE PROCEDURE THE IPG WAS PLACED INTO SURGERY MODE MULTIPLE TIMES AND EXITED AS RECOMMENDED. THEREAFTER, THE IPG FAILED TO ESTABLISH COMMUNICATION WITH EXTERNAL DEVICE. RECOVERY EFFORTS WERE UNSUCCESSFUL AND THE IPG WAS DEEMED INOPERABLE. SURGICAL INTERVENTION TOOK PLACE AGAIN ON (B)(6) 2024 WHERE THE IPG WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400597 PROCLAIM¿ DRG IMPLANTABLE PULSE GENERATOR DRG IPG PMP ABBOTT MEDICAL 3664 T00005158 05415067020215

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other DRG EXTENSIONS (X4)| DRG LEADS (X3)