BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 18936770 · Received March 19, 2024

    Report

    Report Number
    1627487-2024-07501
    Event Type
    Injury
    Date Received
    March 19, 2024
    Date of Event
    February 7, 2024
    Report Date
    April 3, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: DRG LEAD, MODEL: MN10450-50A, UDI: (B)(6), SERIAL: (B)(6), BATCH: 7161025 COMMON DEVICE NAME: DRG LEAD, MODEL: MN10450-50A, UDI: (B)(6), SERIAL: (B)(6), BATCH: 7161025

    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 PATIENT WAS UNABLE TO SET THEIR IPG TO MRI MODE. FURTHER INVESTIGATION REVEALED HIGH IMPEDANCE ON ONE OF THE LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHERE THE PATIENT'S SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. THE INVESTIGATION DID NOT DETERMINE WHICH LEAD HAD HIGH IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966843 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG IPG PMP ABBOTT MEDICAL MN10450-50A 6979490 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other DRG IPG.| DRG LEAD(X2).