BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 17870396 · Received October 4, 2023

    Report

    Report Number
    1627487-2023-04698
    Event Type
    Injury
    Date Received
    October 4, 2023
    Date of Event
    September 12, 2023
    Report Date
    October 4, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT 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. 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: 8830818.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S LEAD HAD MIGRATED AND EXITED THE INCISION. SURGICAL INTERVENTION TOOK PLACE WHERE THE LEAD WAS EXPLANTED TO ADDRESS THE ISSUE AND TREATED WITH ANTIBIOTICS. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE EVENT. 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: 8830818.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122591 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 8830818 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Other DRG IPG.| DRG LEAD.