BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3395429 · Received October 8, 2013

    Report

    Report Number
    3004209178-2013-17672
    Event Type
    Injury
    Date Received
    October 8, 2013
    Report Date
    September 17, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37601, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387S-40, LOT# V241399, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V241399, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT¿S DEVICE SYSTEM WAS REMOVED DUE TO INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. SEE MFR. REPORT # 3004209178-2013-17670. IT WAS UNCLEAR WHICH DEVICE WAS REMOVED DUE TO INFECTION.

    Description of Event or Problem · 1

    THE PATIENT'S HEALTH CARE PROVIDER REPORTED ON (B)(6) 2013 THAT THE LOCATION OF THE INFECTION WAS AT THE RIGHT LEAD AREA. A CULTURE WAS DONE. ANTIBIOTIC TREATMENT AND FOLLOW UP WITH THE DOCTOR WAS REQUIRED. THE RIGHT LEAD WAS RE-IMPLANTED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509598 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention