BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2936187 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-01164
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    January 18, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 7495-51 LOT# SERIAL# (B)(4), PRODUCT TYPE EXTENSION PRODUCT ID, 7495-51 LOT# SERIAL# (B)(4), PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT ACQUIRED AN INFECTION. THE PATIENT HAD SWELLING, ERYTHEMA, DRAINAGE, AND DEHISCENCE AT THE INCISION SITE. THE PATIENT ALSO REPORTED WORSENING OF DISEASE SYMPTOMS. THE BATTERY AND EXTENSIONS WERE EXPLANTED. TWELVE DAYS LATER, THE PATIENT RECEIVED A NEW BATTERY, EXTENSIONS AND LEADS. THE PATIENT REQUIRED INPATIENT HOSPITALIZATION. THE PATIENT RECOVERED WITH SEQUELAE. NO FURTHER INFORMATION WAS REPORTED. FURTHER INFORMATION HAS BEEN REQUESTED AND IF FURTHER INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROVIDER (HCP) REPORTED THAT THE DATE OF DIAGNOSIS OF THE INFECTION WAS ON (B)(6) 2012. PERIOPERATIVE AND INTRAVENOUS ANTIBIOTICS WERE ADMINISTERED. IT WAS STATED THAT THE PATIENT DID NOT HAVE MENINGITIS. IN ADDITION TO SWELLING AND DRAINAGE, THE PATIENT'S SYMPTOMS WERE REDNESS AND POCKET EROSION. THE PRIMARY LOCATION OF THE INFECTION WAS AT THE DEVICE POCKET. A CULTURE WAS OBTAINED, BUT THE RESULTS WERE UNKNOWN. IT WAS NOTED THAT THERE WAS A PARTIAL REMOVAL OF THE STIMULATION SYSTEM. THE PATIENT'S INFECTION HAD RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40232 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| O| R