BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 12856651 · Received November 22, 2021

    Report

    Report Number
    1627487-2021-18537
    Event Type
    Injury
    Date Received
    November 22, 2021
    Date of Event
    November 4, 2021
    Report Date
    November 22, 2021
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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.  DATE OF EVENT IS ESTIMATED.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-18536. IT WAS REPORTED THAT BOTH OF THE PATIENT'S L1 LEADS HAD MIGRATED. AS A RESULT, THE PHYSICIAN EXPLANTED AND REPLACED THE PATIENT'S L1 LEADS. SURGICAL INTERVENTION RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1751547 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 7424452 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other DRG IPG| DRG LEAD X 2