BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA SR

    MDR report key: 2130983 · Received June 16, 2011

    Report

    Report Number
    6000144-2011-03426
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 20, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION 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 WAS NOT RESPONDING TO A DONUT MAGNET APPLICATION AND THAT APPLICATION OF THE MAGNET CAUSED THE PATIENT'S RATE TO DECREASE. IT WAS ALSO REPORTED THAT THE INITIAL IMPLANT PROCEDURE OF THE SYSTEM WAS DIFFICULT, AND THE RIGHT VENTRICULAR LEAD THRESHOLD INCREASED TO A HIGH VALUE SOON AFTER IMPLANT. THE DEVICE OUTPUT WAS PROGRAMMED HIGHER TO ACCOMMODATE THE INCREASED LEAD THRESHOLD. IT WAS FURTHER REPORTED THAT THE DEVICE HAD LESS THAN 1-5 MONTHS BATTERY LONGEVITY REMAINING SO THE PHYSICIAN ELECTED TO REPLACE IT, CITING POSSIBLE EARLY BATTERY DEPLETION. THE LEAD WAS ALSO REPOSITIONED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NOT RESPONDING TO A DONUT MAGNET APPLICATION AND THAT APPLICATION OF THE MAGNET CAUSED THE PATIENT'S RATE TO DECREASE. THE DEVICE IS STILL 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
    1 ADAPTA SR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. ADSR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| O| R 5076 IMPLANTABLE PACING LEAD