BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 90CM

    MDR report key: 9772296 · Received February 28, 2020

    Report

    Report Number
    1627487-2020-02273
    Event Type
    Injury
    Date Received
    February 28, 2020
    Date of Event
    January 21, 2020
    Report Date
    March 27, 2020
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    PMP
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 MFR REPORT: 1627487-2020-022732. IT WAS REPORTED THE PATIENT'S DRG SYSTEM WAS EXHIBITING HIGH IMPEDANCE. REPORTEDLY, THE ISSUE BEGIN AFTER THE PATIENT UNDERWENT A PHYSICAL THERAPY SESSION WHERE THE THERAPIST PLACED SOMETHING RIGHT ON TOP OF THE PATIENT'S BACK WHERE THE LEADS ARE PLACED. THE PATIENT FELT PAIN AND STATED THE SYSTEM STIMULATION STRENGTH CANNOT BE INCREASED. SURGICAL INTERVENTION MAY BE TAKEN TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    RELATED MFR REPORT: 1627487-2020-02272. ADDITIONAL INFORMATION RECEIVED IDENTIFIED THE PATIENT'S LEAD AT THE T12 PLACEMENT WAS REPLACED WITHOUT COMPLICATIONS AND THE REPORTED ISSUE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232443 KIT IMPLANTABLE SLIM TIP LEAD, 90CM DRG LEAD PMP ST. JUDE MEDICAL - NEUROMODULATION MN10450-90A AB2376

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other MN10450-50A, DRG LEAD