BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3431766 · Received October 28, 2013

    Report

    Report Number
    3004209178-2013-19737
    Event Type
    Injury
    Date Received
    October 28, 2013
    Report Date
    October 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
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 748351, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# VA05K31, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V971421, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 748351, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# VA05K31, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4). NO DEVICE ANALYSIS WAS PERFORMED; THE DEVICE MET RISK BASED CRITERIA.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS), LEAD AND EXTENSION WERE EXPLANTED ON (B)(6) 2013. THE SYSTEM WAS EXPLANTED DUE TO INFECTION. THERE WAS NO PATIENT DEATH OR INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THE EXPLANT DATE WAS (B)(6) 2013. IT WAS NOTED THAT PRE-OPERATIVE ANTIBIOTICS WERE USED. THE DIAGNOSIS/ONSET OF INFECTION WAS ON (B)(6) 2013. PATIENT SIGNS AND SYMPTOMS INCLUDED REDNESS, INCISIONAL WOUND OPENING, AND DRAINAGE. THE PRIMARY LOCATION OF THE INFECTION WAS AT THE DEVICE POCKET AND LEAD TRACK. A CULTURE WAS OBTAINED FROM THE DEVICE POCKET AND (B)(6) WAS THE ORGANISM CULTURED. TREATMENT FOR INFECTION INCLUDED BOTH AN INTRAVENOUS THERAPY (IV) AND ORAL ANTIBIOTICS ALONG WITH TOTAL DEVICE SYSTEM EXPLANT. THE INFECTION RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550842 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention