BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 3992739 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14774
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT CALLED AND REPORTED THAT FOR THE LAST FEW DAYS THEY HAVE FELT LITTLE LOW VOLTAGE TINGLING/LIKE ITTY BITTY NEEDLE STICKS/ INTERMITTENT/LIKE A WIRE CAME LOOSE OR EXPOSED ITSELF. THE PATIENT NOTED THAT THEY FELT WEAK AND OUT OF IT AND THE DAY BEFORE THEY WERE UNABLE TO COMPLETE THEIR ROUND OF GOLF. FOLLOW-UP WITH THE CLINIC WAS CONDUCTED AND FROM THE INFORMATION OBTAINED IT WAS REPORTED THAT THE PATIENT HAS BEEN SEEN SINCE AND THAT A DEVICE CHECK WAS DONE AND THERE WAS APPROPRIATE PACEMAKER FUNCTION. THE PATIENT¿S MEDICATIONS WERE CHANGED AND THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471505 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDRL1

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention 5076 X2 LEAD