BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2647966 · Received July 10, 2012

    Report

    Report Number
    1644487-2012-01727
    Event Type
    Malfunction
    Date Received
    July 10, 2012
    Date of Event
    June 19, 2012
    Report Date
    June 19, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA; "ADDITIONAL INFORMATION WAS RECEIVED WHICH CHANGES THE PRODUCT AND PATIENT INITIALLY REPORTED".

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012, WHEN THE REGIONAL MANAGER CLARIFIED THAT THE VNS PATIENT WAS NOT AT THE CLINICAL VISIT (B)(6) WHEN TROUBLESHOOTING WAS PERFORMED ON THE PROGRAMMING SYSTEM, BUT THE PATIENT IS EXPECTED TO RETURN TO THE OFFICE ON (B)(6) 2012. THE PHYSICIAN CONFIRMED THAT SHE WOULD BE INTERROGATING AND PERFORMING DIAGNOSTICS AT THAT TIME. THE PROGRAMMING SYSTEM AGAIN WAS STATED TO BE WORKING FINE AFTER THE 9V BATTERY IN THE WAND WAS REPLACED. THE NURSE LATER REPORTED ON (B)(6) 2012, THAT THE PATIENT WAS SEEN ON (B)(6) 2012 AND THEY WERE UNABLE TO INTERROGATE THE PATIENT'S DEVICE. THEY DO NOT USE THE PROGRAMMING SYSTEM VERY OFTEN AS THIS IS THE PHYSICIAN'S ONLY VNS PATIENT. THE PATIENT CANCELED HER APPOINTMENT ON (B)(6) 2012 AND WILL NOT BE SEEN UNTIL SOMETIME IN (B)(6), DATE UNKNOWN. THE NURSE CLARIFIED THAT THE ISSUE WAS INDEED THE FAILURE TO PROGRAM THAT RESOLVED WITH THE 9V BATTERY REPLACEMENT IN THE WAND ON (B)(6) 2012, AND NOT A HANDHELD ISSUE LIKE ORIGINALLY REPORTED ON (B)(6) 2012. THE COMMENT THAT THE HANDHELD WOULD NOT HOLD A CHARGE WAS MADE IN ERROR. NO FURTHER INFORMATION WAS AVAILABLE. THE PROGRAMMING HISTORY DATABASE WAS SEARCHED AND IT CONTAINED PROGRAMMING HISTORY FROM DATE OF IMPLANT, (B)(6) 2012. IT APPEARS ACCORDING TO THE PROGRAMMING HISTORY THAT THE PATIENT WAS INTERROGATED ON (B)(6) 2012. THE PATIENT'S SETTINGS WERE OUTPUT=1.75MA/FREQUENCY=30HZ/PULSE WIDTH=500USEC/ON TIME=30SEC/OFF TIME=5MIN/MAGNET OUTPUT=0MA/MAGNET PULSE WIDTH=500USEC/MAGNET ON TIME=60SEC ON (B)(6) 2012. SYSTEM DIAGNOSTICS SHOWED THE DEVICE TO BE FUNCTIONING PROPERLY WITH OUTPUT=OK/LEAD IMPEDANCE=OK/DCDC=1/ERI=NO AND NORMAL MODE DIAGNOSTICS SHOWED OUTPUT=OK/LEAD IMPEDANCE=OK/DCDC=2/ERI=NO ON (B)(6) 2012. A BATTERY LIFE CALCULATION WAS PERFORMED WHICH SHOWED 1.11 YEARS REMAINING UNTIL ERI=YES. AS THE NURSE REPORTED THAT THE PATIENT WAS UNABLE TO BE INTERROGATED ON (B)(6) 2012, IT IS UNCLEAR IF THE PATIENT WAS FIRST ABLE TO BE INTERROGATED AND THEN UNABLE TO BE INTERROGATED LATER IN THE CLINIC VISIT SINCE THE PROGRAMMING HISTORY SHOWS THE PATIENT WAS ABLE TO BE INTERROGATED AT SOME POINT THAT DAY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012, WHEN THE MANUFACTURER'S CONSULTANT REPORTED THAT DURING TROUBLESHOOTING OF THE PROGRAMMING SYSTEM IT WAS DISCOVERED THAT THE 9V BATTERY IN THE WAND WAS DEPLETED. AFTER REPLACING THE BATTERY, THE PROGRAMMING SYSTEM WORKED PROPERLY. THE PROGRAMMING SYSTEM WILL NOT BE RETURNED FOR PRODUCT ANALYSIS AS IT IS WORKING PROPERLY.

    Description of Event or Problem · 1

    ON (B)(6) 2012 AN OFFICE ASSISTANT REPORTED THAT THEY NEEDED A REPLACEMENT HANDHELD BECAUSE, IT WOULD NOT HOLD A CHARGE. THEY WOULD CHARGE THE HANDHELD OVERNIGHT, AND IT STILL WOULD NOT STAY CHARGED. THE ASSISTANT COULD NOT CONFIRM HOW LONG THE ISSUE WAS OCCURRING OR THE DEVICE MODEL AND SERIAL NUMBER SINCE THE PHYSICIAN HAD THE HANDHELD AND SHE WAS UNAVAILABLE. ATTEMPTS FOR PRODUCT INFORMATION HAVE BEEN MADE BUT WERE UNSUCCESSFUL. THE HANDHELD HAS NOT BEEN RETURNED FOR PRODUCT ANALYSIS TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR MUZ CYBERONICS, INC. 102 015227

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR