BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4122542 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17818
    Event Type
    Injury
    Date Received
    September 26, 2014
    Report Date
    September 3, 2014
    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: 3387 LOT# J0421698V, IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3387, LOT# J0421701V, IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 7482, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005-08-26 EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005-08-26 EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S INFECTION AT THE DEVICE POCKET WAS DIAGNOSED ON 2014-(B)(6). THE PATIENT HAD SYMPTOMS OF REDNESS AND PAIN. THE PATIENT DID NOT HAVE MENINGITIS. A CULTURE WAS OBTAINED OF THE DEVICE POCKET AND ¿COAG STAPH¿ WAS CULTURED. THE TOTAL SYSTEM WAS EXPLANTED AND IV/ORAL ANTIBIOTICS WERE GIVEN TO THE PATIENT. THE INFECTION HAD RESOLVED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A STAGE 2 DEEP BRAIN STIMULATOR (DBS) PROCEDURE ON THE DAY OF REPORT. THEY HAD AN INFECTION THAT PRESENTED IN (B)(6) AND HAD THE ENTIRE DBS SYSTEM EXPLANTED AT THAT TIME. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601004 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention