BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 19089531 · Received April 11, 2024

    Report

    Report Number
    1627487-2024-08054
    Event Type
    Injury
    Date Received
    April 11, 2024
    Date of Event
    March 22, 2024
    Report Date
    May 10, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    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

    B3 - DATE OF EVENT IS ESTIMATED. THE ALLEGATION IS AGAINST 1 OF 4 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 LEAD MODEL:MN10350-50A, UDI:05415067027153, SERIAL:(B)(6), BATCH: 9193145. COMMON DEVICE NAME: DRG LEAD MODEL:MN10350-50A, UDI:05415067027153, SERIAL:(B)(6), BATCH: 9193145. COMMON DEVICE NAME: DRG LEAD MODEL:MN10350-50A, UDI:05415067027153, SERIAL:(B)(6), BATCH: 9193145.

    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 THE PATIENT EXPERIENCED INADEQUATE STIMULATION WITH THEIR DRG SYSTEM. IN TURN, REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. AS SUCH SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2024, WHERE ALL THE 4 LEADS WERE EXPLANTED AND REPLACED WITH NEW LEADS, THEREBY ADDRESSING EFFECTIVE THERAPY..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691364 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 9193145 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other DRG IPG| DRG LEAD X 3