BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3489926 · Received November 26, 2013

    Report

    Report Number
    3007566237-2013-03854
    Event Type
    Injury
    Date Received
    November 26, 2013
    Report Date
    November 8, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, IMPLANTED: 2013-(B)(6), EXPLANTED: 2013-(B)(6), (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389S-40 LOT# VA0CUWT, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3708660, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708660, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. THE MANUFACTURING (B)(4). ADDITIONAL REVIEW INDICATES THE CORRECT MANUFACTURING (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER STATED THAT "LAST FEW INFECTIONS HAVE BEEN AT BURR HOLE SITE AS WELL AS POCKET," BUT IT WAS UNKNOWN WHAT EVENT THIS PERTAINED TO. THE INFORMATION WAS ALSO REPORTED IN MANUFACTURER'S REPORTS #3004209178-2013-21565, 3004209178-2013-20039, AND 30042091 78-2013-21568.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS AN INFECTION. IT WAS NOTED THAT MANUFACTURER REPRESENTATIVE WAS ALERTED OF A POTENTIAL INFECTION THEY BELIEVED TO BE NEAR THE BURR HOLE CAP. IT WAS NOTED THAT THE PATIENT WOULDSEE THE HEALTH CARE PROFESSIONAL (HCP) AND IT WAS POSSIBLE AN EXPLANT WOULD OCCUR. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SYSTEM WAS EXPLANTED ON 2013-(B)(6). IT WAS NOTED THAT THE INFECTION SEEMED TO BE NEAR THE BURR HOLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT PERIOPERATIVE ANTIBIOTICS HAD BEEN ADMINISTERED, BOTH IV AND ORALLY. IT WAS STATED THAT THE PATIENT DID NOT HAVE MENINGITIS. IT WAS REPORTED THAT THE PATIENT HAD DRAINAGE SYMPTOMS IN ASSOCIATION WITH THE INFECTION. IT WAS REPORTED THAT A CULTURE WAS OBTAINED. IT WAS REPORTED THAT THE TOTAL DEVICE SYSTEM WAS EXPLANTED. IT WAS REPORTED THAT THE INFECTION WAS RESOLVED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614691 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention