BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA

    MDR report key: 2963506 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02380
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    November 14, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS - 5076 IMPLANTABLE PACING LEAD: (B)(6) 2012. (B)(4). DEVICE REMAINS IN USE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT REPORTED "FEELING HEART RATE" AND BECOMING VERY WEAK, HAVING SHORTNESS OF BREATH, AND FEELING "FUNNY". THE PATIENT UNDERSTOOD THAT A TECHNICIAN "TURNED DOWN THE ENERGY LEVEL" AND THE SYMPTOMS RESOLVED. LATER, AFTER THE PATIENT HELD SHEET MUSIC FOR A COUPLE HOURS, THE IMPLANT SITE WAS "KIND OF BRUISED", BECAME ITCHY, AND STARTED TO HURT "LIKE A TOOTHACHE". THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66225 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDRL1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5076 IMPLANTABLE PACING LEAD