BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 17565462 · Received August 17, 2023

    Report

    Report Number
    1627487-2023-03924
    Event Type
    Injury
    Date Received
    August 17, 2023
    Date of Event
    May 7, 2023
    Report Date
    August 31, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: 50CM SLIMTIP LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8081976.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A CAR ACCIDENT, THE PATIENT HAD HIGH IMPEDANCES AND EXPERIENCED LOSS OF COVERAGE AS WELL AS AUTO REDUCING. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN BOTH LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD IS AT FAULT.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER:1627487-2023-04175. ADDITIONAL INFORMATION INDICATES THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO ONE LEAD WITH HIGH IMPEDANCES AND ONE LEAD MIGRATING. SURGICAL INTERVENTION TOOK PLACE ON 08 AUGUST 2023 WHEREIN THE LEADS WERE EXPLANTED, REPLACED AND AN ADDITIONAL LEAD WAS IMPLANTED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962318 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 8006083 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Other DRG IPG| DRG LEAD