BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 90CM

    MDR report key: 9858248 · Received March 19, 2020

    Report

    Report Number
    1627487-2020-02918
    Event Type
    Injury
    Date Received
    March 19, 2020
    Date of Event
    February 2, 2020
    Report Date
    August 3, 2020
    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

    CORRECTION: ADDITIONAL INFORMATION FOUND - SECTION H6: METHOD CODE SHOULD HAVE BEEN 4114 RATHER THAN 4117.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-023217 1627487-2020-023218 ADDITIONAL INFORMATION FOUND THE PATIENT HAD THEIR 2-L5 LEADS AND 1 OF THEIR S1 LEADS EXPLANTED AND REPLACED TO ADDRESS THE HIGH IMPEDANCE ISSUE. NOTE: IT IS UNKNOWN WHICH S1 LEAD HAD HIGH IMPEDANCE AND WAS REPLACED, AS SUCH BOTH S1 LEADS ARE BEING REPORTED.

    Additional Manufacturer Narrative · 1

     THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-02919. IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320869 KIT IMPLANTABLE SLIM TIP LEAD, 90CM DRG SLIM TIP LEAD PMP ST. JUDE MEDICAL - NEUROMODULATION MN10450-90A 6151577 05415067027160

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other MODEL # MN10450-50A| MODEL # MN10450-50A - LEAD (X2)| MODEL # MN10450-50A