BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE PC

    MDR report key: 10292005 · Received July 17, 2020

    Report

    Report Number
    3006630150-2020-02978
    Event Type
    Injury
    Date Received
    July 17, 2020
    Date of Event
    June 28, 2020
    Report Date
    July 17, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729984467
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT DEVICES: MODEL NUMBER DB-2201-45-DC, LEAD KIT 45CM, SERIAL NUMBER (B)(4). MODEL NUMBER NM-3138-55, 55CM 8 CONTACT EXTENSION, SERIAL NUMBER (B)(4). MODEL NUMBER DB-4600-C, SURETEK BURR HOLE COVER KIT, LOT NUMBER 23198104 AND 25109009.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HEADACHES DURING STIMULATION. THERE WERE MULTIPLE ATTEMPTS TO REPROGRAM HOWEVER THAT DID NOT RESOLVE THE COMPLAINT. IN ADDITION, THE PHYSICIAN WAS CONCERNED ABOUT INFECTION AS THE PATIENT REPORTED SOME SWELLING IN HIS NECK. THE PATIENT UNDERWENT AN EXPLANT OF THE ENTIRE SYSTEM AND DURING THE SURGERY THE PHYSICIAN NOTED THERE WAS NO OVERT SIGN OF INFECTION. A LARGE PART OF WHY THE PHYSICIAN CHOSE TO EXPLANT THE PATIENT WAS DUE TO HIS CONCERN ABOUT INFECTION. CULTURES WERE TAKEN HOWEVER THE RESULTS WERE NEGATIVE. THE SWELLING IN THE PATIENT'S NECK HAS RESOLVED WITHOUT INTERVENTION. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753264 VERCISE PC STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1140-S 631129 08714729984467

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention