BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 90CM

    MDR report key: 10202723 · Received June 26, 2020

    Report

    Report Number
    1627487-2020-21829
    Event Type
    Injury
    Date Received
    June 26, 2020
    Date of Event
    June 9, 2020
    Report Date
    January 4, 2021
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    PMP
    UDI-DI
    05415067027160
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO ABBOTT THAT THE PATIENT HAD HIGH IMPEDANCE. REO MET WITH PATIENT ON (B)(6) 2020 AND FOUND THAT THEIR T12 LEAD HAS HIGH IMPEDANCE ON ALL CONTACTS. THE PATIENT DID NOT REPORT ANY FALLS OR TRAUMA. REP WAS ABLE TO PROGRAM THE PATIENT WITH THEIR REMAINING LEADS. THE PATIENT WILL HAVE THE LEAD REVISED SOMETIME IN THE FUTURE, BUT NO SURGERY DATE IS SET YET. ALTHOUGH THE ISSUE WAS RESOLVED IN THE FIELD, THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE, AND THE ROOT CAUSE OF THE REPORTED INCIDENT IS UNKNOWN AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS ESTIMATED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE PATIENT HAD TWO DRG LEADS IMPLANTED BILATERALLY AT T12 TO ADDRESS THE ISSUE. THE LEFT T12 LEAD WAS EXPLANTED.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER 1627487-2020-21828. IT WAS REPORTED THE PATIENT'S T12 LEAD REFLECTS HIGH IMPEDANCE VALUES. REPROGRAMMING WAS ABLE TO PROVIDE THERAPY. HOWEVER, THE PATIENT MAY UNDERGO SURGICAL INTERVENTION AT A LATER DATE TO FURTHER ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666819 KIT IMPLANTABLE SLIM TIP LEAD, 90CM DRG SLIM TIP LEAD PMP ST. JUDE MEDICAL - NEUROMODULATION MN10450-90A AB2440 05415067027160

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other MODEL MN10450-90A, LEAD