BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4763568 · Received May 11, 2015

    Report

    Report Number
    3007566237-2015-01267
    Event Type
    Injury
    Date Received
    May 11, 2015
    Report Date
    April 23, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3389S-40, LOT # V230719, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT # V230719, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37085-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2015, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT # V230719, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT # V230719, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37601, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37085-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2015, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION; PRODUCT ID 3389S-40, LOT# V230719, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3389S-40, LOT# V230719, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 37601, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT HAD PREVIOUSLY HAD THE INS EXPLANTED DUE TO AN INFECTION AT THE POCKET SITE. THE BILATERAL LEADS AND EXTENSIONS HAD REMAINED BUT ON THE DATE OF THIS REPORT WERE REMOVED DUE TO THE SAME INFECTION. THERE WAS NO ALLEGED PRODUCT ISSUE. THE EQUIPMENT WAS TESTED FOR AN INFECTION. IT WAS NOTED THAT THE DEVICES WOULD BE REPLACED IN THE FUTURE. THE INFECTION WAS BACTEREMIA AND A CULTURE WAS TAKEN THAT HAD INDICATED THE ORGANISM WAS STAPH EPIDERMIDIS, FUNGAL, GRAM STAIN. SYMPTOMS INCLUDED REDNESS AND SWELLING AND THE LOCATION OF THE ISSUE/SYMPTOM WAS THE LEFT SIDE IMPLANT, LEAD EXTENSION CONNECTION LOCATION AND LEAD LOCATION. DATE OF ONSET/DIAGNOSES WAS ONGOING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) NOTED THAT ANTIBIOTICS WERE GIVEN TO THE PATIENT, BUT IT WAS UNKNOWN WHAT TYPE. THE REP HAD NO FURTHER INFORMATION ON HOW THE PATIENT WAS DOING OR IF THE INFECTION RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INFECTION AT THE LEFT SIDE DEVICE POCKET. A CULTURE WAS TAKEN FROM THE POCKET. THE ORGANISM CULTURED WAS STAPHYLOCOCCUS EPIDERMIS PROPIONIBACTERIUM ACHNES. ANTIBIOTIC TREATMENT WAS REQUIRED. DATE OF ONSET WAS UNKNOWN. THE PATIENT HAD REDNESS. THE IMPLANTABLE NEUROSTIMULATOR (INS) AND PARTIAL EXTENSIONS WERE EXPLANTED ON (B)(6) 2015. THE LEADS REMAINED. PATIENT STATUS WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307228 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention