BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 1791450 · Received August 10, 2010

    Report

    Report Number
    6000144-2010-03093
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    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. PREVIOUS EXPERIENCE FROM A RETRO REVIEW FOR DEVICES STILL IN USE HAS BEEN INCORPORATED INTO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REPORTS "GETTING HIT HARD, THUMPING 5 TIMES IN A ROW EVERY 3 HOURS" AND THAT HIS HEART RATE IS IN THE 80'S IF HE GETS UP AND CROSSES THE ROOM. PATIENT STATED "I NEARLY BLACKOUT" AND HE THINKS THE DEVICE IS NOT WORKING RIGHT. HE HAS HAD MEDICATION CHANGES AND HAS BEEN TOLD THE DEVICE CHECKS ARE OK. PREVIOUS EXPERIENCE WITH THIS DEVICE INCLUDES THE PATIENT FEELING " '5 HITS' EVERY 3 HOURS ON THE MINUTE SINCE IMPLANT" AND THAT HIS PREVIOUS PACEMAKER DID THE SAME THING FOR 4.5 YEARS. 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 IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. ADDR06 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other 4011 IMPLANTABLE PACING LEAD| 4511 IMPLANTABLE PACING LEAD