BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3160226 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-10062
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 20, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE EVENT DATE WAS INITIALLY REPORTED TO BE THE EXPLANT DATE OF THE DEVICE. ADDITIONAL REVIEW INDICATED THE FOLLOWING CONCOMITANT PRODUCTS MADE UP THE PATIENT'S IMPLANTED SYSTEM AT THE TIME OF THE INFECTION. CONCOMITANT PRODUCTS: PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# V358538, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT# V358538, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# V358538, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# V358538, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# V358538, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# V358538, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE ONSET OF THE INFECTION WAS BETWEEN (B)(6) 2012. PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED AND THE PATIENT DID NOT HAVE MENINGITIS. THE PRIMARY LOCATION OF THE INFECTION WAS AT THE DEVICE POCKET AND THE ¿CATHETER OR LEAD TRACK.¿ INFORMATION REASONABLY SUGGESTS THE LATTER WAS REFERRING TO THE EXTENSIONS AS THEY WERE REMOVED AND THE PATIENT¿S LEADS WERE NOT. SYMPTOMS OF INFECTION INCLUDED REDNESS AND PAIN. A CULTURE FROM THE DEVICE POCKET SHOWED A (B)(6) COAGULASE NEGATIVE. A PARTIAL DEVICE SYSTEM EXPLANT WAS REQUIRED FOR TREATMENT IN ADDITION TO IV ANTIBIOTICS. IT WAS STATED THE INFECTION HAD RESOLVED. IT WAS FURTHER NOTED THE PATIENT HAD A ¿DEBILITATED STATUS,¿ INDICATED TO BE A RISK FACTOR PRIOR TO BEING IMPLANTED WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS STIMULATOR AND EXTENSIONS WERE REMOVED DUE TO INFECTION. ADDITIONAL INFORMATION WAS REQUESTED. IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260755 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention