BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA

    MDR report key: 3051533 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05968
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 22, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 PRODUCT: 1388TC COMPETITOR IMPLANTABLE PACING LEAD (B)(6) 2000. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS FEELING PACING ON THEIR LEFT SIDE WHEN BENDING FORWARD. THE DEVICE WAS REPROGRAMMED BY DISABLING THE ADAPTIVE FEATURE. THIS DID RESOLVE THE ISSUE. THE DEVICE IS STILL 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
    152823 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDRL1

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention 4076 IMPLANTABLE PACING LEAD