BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B

    MDR report key: 16454613 · Received February 28, 2023

    Report

    Report Number
    1627487-2023-00854
    Event Type
    Injury
    Date Received
    February 28, 2023
    Date of Event
    February 2, 2023
    Report Date
    June 6, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MHY
    UDI-DI
    05415067030320
    PMA / PMN Number
    P140009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: DBS LEAD, MODEL: 6172, UDI: (B)(4), SERIAL: (B)(4), BATCH: 8122457. DATE OF EVENT IS ESTIMATED.

    Additional Manufacturer Narrative · 0

    DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE PATIENT INFORMATION. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, A SINGLE DEFINITIVE ROOT CAUSE FOR THE ISSUE ENCOUNTERED WAS UNABLE TO BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT NEVER HAD EFFECTIVE THERAPY WITH THE SYSTEM IMPLANTED. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023, WHERE BOTH LEADS WERE EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657458 8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B DBS LEAD MHY ABBOTT MEDICAL 6172 8122457 05415067030320

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Other 2X BURR HOLE CAPS.| 2X EXTENSIONS.| DBS IPG.