BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 4241414 · Received November 10, 2014

    Report

    Report Number
    3004209178-2014-21258
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    September 20, 2011
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# V050963, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# V012588, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT LEAD WAS EXPOSED DUE TO FALL/INJURY. THE PATIENT HAD FALLEN IN THEIR GARAGE AND HIT THE RIGHT SIDE OF THEIR HEAD WHICH RESULTED IN A WOUND TO THE RIGHT SCALP. THE PATIENT WAS TAKEN TO THE EMERGENCY DEPARTMENT FOR SUTURES AND THE NEUROSURGEON WAS CONSULTED SINCE THE LEAD WAS EXPOSED. INTERVENTION INVOLVED RE-SUTURING OF THE LEAD TRACT. THE EVENT WAS RELATED TO THE DEVICE OR THERAPY AND NOT RELATED TO THE PROCEDURE. THE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721801 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention