BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 2790195 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05406
    Event Type
    Injury
    Date Received
    October 15, 2012
    Report Date
    January 9, 2013
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    Z-2120-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) - WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. BATTERY DEPLETION INDICATED. ELECTIVE REPLACEMENT INDICATOR (ERI) ON (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) - THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WENT TO ELECTIVE REPLACEMENT INDICATOR PREMATURELY. THE PATIENT WENT INTO CARDIAC ARREST AND IS CURRENTLY HOSPITALIZED FOR A SYSTEMIC INFECTION. IT WAS ALSO NOTED THAT THE DEVICE WAS PROGRAMMED TO CONSUME POWER AT A MUCH HIGHER RATE THAN NORMAL. A DEVICE CHANGEOUT IS PLANNED. 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
    1 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL, INC. ADDRL1

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R 4076 X 2 IMPLANTABLE PACING LEADS