BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 4447953 · Received January 23, 2015

    Report

    Report Number
    3004209178-2015-01165
    Event Type
    Injury
    Date Received
    January 23, 2015
    Report Date
    January 5, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3387S-40, LOT# V902308, IMPLANTED: 2012 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S LEFT SYSTEM GOT INFECTED AND HAD TO BE EXPLANTED. A PATIENT INJURY WAS REPORTED. THE PATIENT WAS IN THE HOSPITAL IN (B)(6) 2013 AND WAS BEING TREATED FOR INFECTION. IN (B)(6) 2014, THE SYSTEM WAS TAKEN OUT DUE TO THE INFECTION. FOLLOW UP WITH THE PATIENT¿S HEALTHCARE PROFESSIONAL (HCP) INDICATED THE INFECTION WAS DIAGNOSED ON 2014 (B)(6). THE PATIENT HAD SYMPTOMS OF REDNESS, DRAINAGE, PAIN, AND INCISIONAL WOUND OPENING. THE PATIENT¿S WOUND HAD BEEN WASHED OUT ON 2013 (B)(6). THE PATIENT DID NOT HAVE MENINGITIS AND PERIOPERATIVE ANTIBIOTICS HAD BEEN ADMINISTERED. A CULTURE WAS OBTAINED AND (B)(6 WAS CULTURED. TREATMENT INCLUDED TOTAL SYSTEM EXPLANT AND IV ANTIBIOTICS. AFTER TREATMENT THE INFECTION HAD RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56866 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention