BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2935842 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-01139
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    January 10, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION: PRODUCT ID 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION: PRODUCT ID 3387S-40, LOT# V825941, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3387S-40, LOT# V825941, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DEVELOPED AN INFECTION AFTER THE IMPLANT PROCEDURE. IT WAS STATED THE IMPLANT PROCEDURE TOOK PLACE IN (B)(6) 2012. PER MANUFACTURER'S REGISTRATION SYSTEM THE IMPLANT PROCEDURE OCCURRED IN (B)(6) 2012. THE INFECTION WAS DESCRIBED AS A "DEEP BRAIN INFECTION." IT WAS STATED TO HAVE LASTED UNTIL SEPTEMBER 2012. IT WAS NOTED THE PATIENT WAS DOING "PRETTY GOOD NOW." ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE HEALTHCARE PROVIDER STATED THE PATIENT'S INFECTION WAS DIAGNOSED ON (B)(6) 2012 AND THE PATIENT SHOWED SYMPTOMS OF FEVER, REDNESS, SWELLING, DRAINAGE AND PAIN. IT WAS STATED THE LOCATION OF THE INFECTION WAS THE PATIENT'S LEAD TRACK. THE HEALTHCARE PROVIDER REPORTED A CULTURE WAS OBTAINED FOR PROPIONIBACTERIA BUT THE CULTURE SOURCE WAS UNKNOWN. IT WAS STATED THE PATIENT WAS ADMINISTERED BOTH ORAL AND INTRAVENOUS ANTIBIOTICS AFTER THE INFECTION AND IT WAS UNKNOWN IF PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED. IT WAS REPORTED THE PATIENT HAD A TOTAL DEVICE SYSTEM EXPLANT AS A TREATMENT FOR THE INFECTION. THE HEALTHCARE PROVIDER STATED THE PATIENT'S INFECTION WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40914 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention