BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 90CM

    MDR report key: 18212869 · Received November 27, 2023

    Report

    Report Number
    1627487-2023-05311
    Event Type
    Injury
    Date Received
    November 27, 2023
    Date of Event
    October 16, 2023
    Report Date
    May 13, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027160
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF THE EVENT IS ESTIMATED. DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE PATIENT INFORMATION. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: DRG LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL:(B)(6), BATCH: 7279702. COMMON DEVICE NAME: DRG LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8041925.

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. CORRECTION B1: ADVERSE EVENT AND PRODUCT PROBLEM SHOULD HAVE BEEN CHECKED INSTEAD OF ADVERSE EVENT. CORRECTION: H6 2388 - INADEQUATE PAIN RELIEF AND 1924 - FAILURE OF IMPLANT SHOULD HAVE BEEN SELECTED INSTEAD OF JUST 2388 - INADEQUATE PAIN RELIEF.

    Additional Manufacturer Narrative · 0

    CORRECTION: H11 SHOULD HAVE READ: DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE PATIENT INFORMATION. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: DRG LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7279702. INSTEAD OF: DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE PATIENT INFORMATION. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: DRG LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7279702. COMMON DEVICE NAME: DRG LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8041925.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION AND THE THERAPY STRENGTH IS DECREASING ON ITS OWN . X-RAYS INDICATED THE LEAD WAS FRACTURED. SURGICAL INTERVENTION MAY OCCUR TO ADDRESS THE ISSUE. THE INVESTIGATION DID NOT DETERMINE WHICH LEAD HAD FRACTURED.

    Description of Event or Problem · 0

    IT WAS REPORTED ONE OF THE T12 LEADS WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THE INVESTIGATION DID NOT DETERMINE WHICH LEAD HAD FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229282 KIT IMPLANTABLE SLIM TIP LEAD, 90CM DRG LEAD PMP ABBOTT MEDICAL MN10450-90A 7279702 05415067027160

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other DRG IPG.| DRG LEAD (2).