BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 6144526 · Received December 1, 2016

    Report

    Report Number
    MW5066496
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    November 4, 2016
    Report Date
    November 4, 2016
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAS AN AICD THAT WAS PART OF ST. JUDE MEDICAL RECALL. HE WAS SENT A LETTER FROM US WITH THE RECOMMENDATION FROM ST. JUDE TO KEEP A REMOTE MONITOR PLUGGED IN AT ALL TIMES. PT WAS HAVING TROUBLE KEEPING MONITOR COMMUNICATING AND CALLED MERLIN FOR ASSISTANCE. THEY WERE TOLD THEY WOULD BE SENT A NEW MONITOR. IN A F/U CALL TODAY, PT'S WIFE TOLD ME THEY HAD NOT RECEIVED THE MONITOR YET. I CALLED MERLIN AND AFTER A 44 MINUTE WAIT ON HOLD WAS FINALLY ABLE TO TALK TO SOMEONE. I WAS INFORMED THAT THE MONITORS ARE ON BACK ORDER BUT THAT PTS WITH RECALLED DEVICES WERE A PRIORITY. PT'S INITIAL CONTACT REQUESTING A NEW MONITOR WAS ON (B)(6) 2016 PER MERLIN. THEY SAID THE WAIT TIME FOR PTS WITH RECALLED DEVICES WAS 2 TO 3 WEEKS AND THAT OUR PT SHOULD BE RECEIVING HIS MONITOR NEXT WEEK. THIS IS AN UNACCEPTABLE TIME AND DOES NOT MEET WITH THE RECOMMENDATIONS THEY PUT IN THEIR RECALL NOTIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791086 ST. JUDE MEDICAL MERLIN REMOTE MONITOR NIK ST. JUDE MEDICAL EX1150

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other