BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3524064 · Received December 17, 2013

    Report

    Report Number
    3004209178-2013-23671
    Event Type
    Injury
    Date Received
    December 17, 2013
    Date of Event
    November 30, 2013
    Report Date
    December 2, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V022878, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION; PRODUCT ID 3387S-40, LOT# V022878, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION; PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION; PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INFECTION. THE PATIENT HAD SWELLING, REDNESS AND TENDERNESS AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE. INFECTION STARTED ON THE SATURDAY (B)(6) 2013. THE PATIENT WAS SEEN IN THE CLINIC ON SATURDAY AND ON THE DATE OF THIS REPORT WOULD BE HAVING THE LEFT INS AND EXTENSION REMOVED AND TREATED WITH ANTIBIOTICS. IT WAS NOTED THAT THE HEALTHCARE PROFESSIONAL USUALLY WAITED 6 MONTHS TO RE-IMPLANT. IT WAS NOTED THAT THE NURSE HAD SEEN THE PATIENT TWO WEEKS PRIOR TO THE DATE OF THIS REPORT TO REMOVE STAPLES AND EVERYTHING HAD BEEN FINE THEN. ADDITIONAL INFORMATION RECEIVED REPORTED THAT A CULTURE WAS DONE ON (B)(6) 2013 AND THE RESULTS WERE PENDING. LOCATION OF THE INFECTION WAS THE LEFT GENERATOR. DEVICE WAS EXPLANTED. NO ADDITIONAL INTERVENTIONS WERE TAKEN OR PLANNED. PATIENT OUT COME WAS NOT RECEIVING THERAPY.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THE PATIENT¿S CULTURE SWAB WAS RETURNED AND IT WAS FOUND THERE WERE NO ORGANISMS. IT WAS NOTED THAT THE PATIENT SAW THEIR HEALTH CARE PROVIDER (HCP) ONE DAY PRIOR TO REPORT FOR FOLLOW UP AND THE PATIENT IS ¿DOING GREAT¿. IT WAS REPORTED THE PATIENT WILL BE ON ANTIBIOTICS FOR TWO WEEKS AND SEE THEIR HCP IN FOUR WEEKS FOR MORE BLOOD WORK. IT WAS NOTED BY THE HCP THAT IF ¿EVERYTHING IS CLEAR¿ THEY WILL SCHEDULE A DATE TO RE-IMPLANT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658722 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention