BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 17346180 · Received July 18, 2023

    Report

    Report Number
    1627487-2023-03294
    Event Type
    Injury
    Date Received
    July 18, 2023
    Date of Event
    June 23, 2023
    Report Date
    September 25, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL:(B)(6), LOT: 7982307.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2023 WHEREIN AND THE LEADS WERE EXPLANTED AND REPLACED RESTORING THERAPY.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S LEADS MIGRATED AFTER A BACK SURGERY. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE EVENT. THE ISSUE WAS CONFIRMED VIA X-RAYS. IN TURN, SURGICAL INTERVENTION MAY TAKE PLACE LATER TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766662 KIT IMPLANTABLE SLIM TIP LEAD, 50CM SCS LEAD PMP ABBOTT MEDICAL MN10450-50A 7982307 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 21 MO Female Other DRG ANCHOR (X2)| DRG IPG| DRG LEAD