BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4250059 · Received November 14, 2014

    Report

    Report Number
    3004209178-2014-21573
    Event Type
    Injury
    Date Received
    November 14, 2014
    Report Date
    October 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389S-40, LOT# VA0MTGS, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389S-40, LOT# VA0MTGS, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3389S-40, LOT# VA0MTGS, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED PERIOPERATIVE ANTIBIOTICS WERE USED. ONSET OR DIAGNOSIS OF THE INFECTION OCCURRED ON (B)(6) 2014. THE PATIENT DID NOT HAVE MENINGITIS. SIGNS OR SYMPTOMS OF INFECTION INCLUDED REDNESS, DRAINAGE AND INCISIONAL WOUND OPENING. THE PRIMARY LOCATION OF THE INFECTION WAS THE SCALP AND DEEP BRAIN STIMULATOR LEAD CONNECTOR SITE. A CULTURE WAS OBTAINED AND THE ORGANISM CULTURED WAS STAPHYLOCOCCUS EPIDERMIDIS AND ENTEROCOCCUS. TREATMENT INCLUDED INTRAVENOUS ANTIBIOTICS. THE PATIENT OUTCOME WAS THE INFECTION HAD RESOLVED. PATIENT RISK FACTORS PRIOR TO IMPLANT INCLUDED DIABETES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S BATTERY WAS REMOVED DUE TO INFECTION. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736172 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention