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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 105; GENERATOR

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CYBERONICS INC PULSE GEN MODEL 105; GENERATOR Back to Search Results
Model Number 105
Device Problems Disconnection (1171); Difficult to Interrogate (1331); Loose or Intermittent Connection (1371); Failure to Advance (2524); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/01/2014
Event Type  malfunction  
Event Description
It was reported that the unused generator could not be interrogated prior to surgery despite using two programming systems.The first programming system showed the interrogation progress bar but it did not advance any further.A heard reset was performed but the issue did not resolve.The handheld device was confirmed to be unplugged from the power adaptor.The second programming system displayed an ¿unable to open port¿ error message.It was noted that the usb to port connection was loose.The communication issues were confirmed to be not related to the wand battery.Emi is not suspected as other devices have been able to be interrogated.The loose usb to port connection for the tablet device was reported in manufacturer report # 1644487-2014-01875.The unused generator has not been returned to date.Attempts for additional relevant information have been unsuccessful to date.
 
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Brand Name
PULSE GEN MODEL 105
Type of Device
GENERATOR
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key3958794
MDR Text Key14877060
Report Number1644487-2014-01874
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/01/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number105
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 07/01/2014
Initial Date FDA Received07/28/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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