BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3070389 · Received April 22, 2013

    Report

    Report Number
    2124215-2013-06516
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    August 20, 2012
    Report Date
    January 3, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS VERY ACTIVE PATIENT'S PROGRAMMING HAS BEEN OPTIMIZED SEVERAL TIMES TO BETTER WORK WITH THEIR HIGH ACTIVITY LEVELS. AS THE PATIENT EXERCISES, THE DEVICE WILL QUICKLY REACH MAXIMUM SENSING RATE (MSR) BUT THEN MID EXERCISE THE HEART RATE ABRUPTLY DECREASES. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED SOME PROGRAMMING CHANGES TO THE MINUTE VENTILATION (MV) SETTINGS THEN HAVING THE PATIENT PERFORM A HALL WALK TO DETERMINE IF THE CHANGES WERE EFFECTIVE. DURING THE HALL WALK, THE PATIENT'S HEART RATE ONCE AGAIN WENT UP QUICKLY. SEVERAL MORE TROUBLESHOOTING ATTEMPTS WERE MADE TO STABILIZE THE HEART RATE. THIS PATIENT HIKES IN HIGH ELEVATION OF 8000 FEET, AND TS THOUGHT THAT THE HIGH ALTITUDE MIGHT BE A FACTOR IN THE WAY THE MV IS REACTING. SEVERAL CHANGES WERE MADE, WHICH DID KEEP THE HEART RATE HIGHER FOR LONGER, BUT STILL AFTER 35 MINUTES OR SO, THERE WAS SUDDEN DROP IN HEART RATE FOR NO REASON. TS SUGGESTED A DEVICE MEMORY DOWNLOAD SO THAT ENGINEERS CAN SEE WHAT THE DEVICE IS DOING. THE PATIENT WEARS AN ACROSS THE CHEST HEART MONITOR, AND THERE WAS SOME SPECULATION THAT IT COULD BE CAUSING SOME ELECTROMAGNETIC INTERFERENCE (EMI) WITH THE DEVICE. TS ASKED FOR A MEMORY DOWNLOAD TO BE PERFORMED AND SENT IN. BOSTON SCIENTIFIC ENGINEERS RECEIVED THE DISK AND ANALYSIS DECIDED THAT THE DEVICE PROGRAMMING WAS NOT OPTIMAL FOR THE AMOUNT OF EXERCISE THAT THE PATIENT WAS DOING. ADDITIONAL PROGRAMMING CHANGES WERE DONE, AND THE NEXT TIME THE PATIENT WAS SEEN THEY WERE VERY PLEASED WITH THE NEW SETTINGS AND STATED THE CHANGES ARE PERFECT. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171151 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K173

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR 4470| 4137| K173