BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3021213 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04228
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    March 7, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389S-40, LOT# V009893, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INFECTION AT THE RIGHT LEAD INCISION SITE. IT WAS STATED THE HEALTHCARE PROVIDER DID A DEBRIDEMENT ABOUT A YEAR PREVIOUS TO THIS REPORT. IT WAS UNCLEAR IF THE INFECTION RESOLVED. THE BATTERY DEPLETED NORMALLY AND WAS REPLACED DUE TO END OF SERVICE ON THE DATE OF THIS REPORT. IT WAS NOTED THERE WAS A SCAB AT THE RIGHT LEAD INCISION SITE AND THAT "IT STILL HAD NOT HEALED." ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED. REFER TO MANUFACTURER REPORT #3004209178-2013-04227. THIS REPORT PERTAINS TO AN INFECTION IN 2007 WITH THE PATIENT'S PREVIOUS IMPLANTABLE NEUROSTIMULATOR, BUT WITH THE SAME LEAD AND AT THE SAME LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124754 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention