BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3395410 · Received October 8, 2013

    Report

    Report Number
    3004209178-2013-17670
    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) 2012, EXPLANTED: (B)(6) 2013, 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

    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.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508305 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