BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 16064696 · Received December 28, 2022

    Report

    Report Number
    1627487-2022-07130
    Event Type
    Injury
    Date Received
    December 28, 2022
    Date of Event
    September 20, 2022
    Report Date
    December 28, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. 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. DATE OF EVENT IS ESTIMATED. 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. THE ALLEGATION IS AGAINST TWO OF FOUR LEADS; HOWEVER, IT IS UNKNOWN WHICH LEADS, 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)(4), BATCH: 8042800; LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(4), BATCH: 8042800.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBER: 1627487-2022-07132. IT WAS REPORTED THAT THE PATIENT'S LEFT T12 AND L2 LEADS HAD HIGH IMPEDANCES CAUSING INEFFECTIVE THERAPY. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. IT WAS NOTED THAT THE PATIENT HAD A RECENT FALL. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE LEADS WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY ESTABLISHED POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2199325 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG SLIM TIP LEAD PMP ABBOTT MEDICAL MN10450-50A 7974821 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male Other DRG IPG| DRG LEAD (X2)