BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 3153673 · Received June 8, 2013

    Report

    Report Number
    3004209178-2013-08935
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 26, 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
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY- THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    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 PRODUCTS: 4092-52 IMPLANTABLE PACING LEAD (B)(6) 2010; 4574-45 IMPLANTABLE PACING LEAD (B)(6) 2010. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE MAY BE PREMATURE BATTERY DEPLETION. IT WAS ALSO REPORTED PER FLUOROSCOPY ON THE DAY OF THE GENERATOR ANDLEAD CHANGE THE PHYSICIAN NOTED THAT THE TIP OF THE ATRIAL LEAD HAD DROPPED DOWN TO JUST ABOVE THE ANNULUS. IN ADDITION THERE WAS INTERMITTENT CAPTURE UNIPOLAR AND BIPOLAR AT 8V/1 MSEC. THE DEVICE WAS EXPLANTED AND REPLACED. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254100 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R