BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4110836 · Received September 23, 2014

    Report

    Report Number
    3004209178-2014-17549
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3389S-40, LOT # VA07PSVV02, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT # VA07PSVV02, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3708660, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN INFECTION NEAR THE LEAD INCISION. AN EXPLANT WAS REQUIRED AS A RESULT OF THE EVENT. IT WAS UNKNOWN IF ANY TROUBLESHOOTING OR DIAGNOSTIC TESTING WAS PERFORMED. THE CULTURE REVEALED PSEUDOMONAS AT LEAD SCALP INCISION. THE LEAD, EXTENSION, AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WERE EXPLANTED 1 WEEK PRIOR TO REPORT. THE PATIENT STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY AND NO PATIENT SYMPTOMS WERE REPORTED. 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED AND THE DIAGNOSIS DATE OF THE INFECTION WAS (B)(6) 2014. THE PATIENT DID NOT HAVE MENINGITIS AND THEY HAD INCISIONAL WOUND OPENING. THE PRIMARY LOCATION OF THE INFECTION WAS AT THE SCALP INCISION AND A CULTURE WAS OBTAINED FROM THE DEVICE POCKET. IV ANTIBIOTICS AND ORAL ANTIBIOTICS WERE GIVEN AS TREATMENT FOR THE INFECTION AND THE PATIENT¿S INFECTION RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590044 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention