BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 90 CM

    MDR report key: 17560130 · Received August 16, 2023

    Report

    Report Number
    1627487-2023-03911
    Event Type
    Injury
    Date Received
    August 16, 2023
    Report Date
    August 21, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734406116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE IS ESTIMATED. THE ALLEGATION IS AGAINST 1 OF 2 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: QUATTRODE LEAD WIDE, MODEL: 3169ANS, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8080442.

    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 THE PATIENT HAD A SUSPECTED INFECTION AT THE LEAD SITE AND THE PROCEDURE WAS ABORTED. THE PATIENT WAS ON ANTIBIOTICS AND THE INFECTION IS RESOLVED. THE INVESTIGATION DID NOT DETERMINE WHICH LEAD ATTRIBUTED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1933161 QUATTRODE LEAD WIDE SPACED, 90 CM STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW ABBOTT MEDICAL 3169 8080442 05414734406116

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other SCS IPG| SCS LEAD