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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 103 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 02/18/2013
Event Type  Injury  
Event Description

It was reported that following generator and lead replacement surgery on (b)(6) 2013 due to high impedance, the vns patient experienced throat tightness and pain that did not occur with stimulation on-times. The patient was unable to tolerate the device settings that were programmed on the previous device. The patient reported that, since replacement, his face would sometimes swell. Diagnostic results showed normal device function. Follow-up revealed that physician attributed these issues to vns. The patient was given anti-inflammatory medications and his device settings were decreased. The physician also indicated that stress may have contributed to the events and that no medication changes preceded the onset of the events additional information was received stating that the patient also began experiencing numbness in the jaw and neck. The patient¿s seizures were noted to be more frequent and longer in duration. The physician attempted to increase the device settings but was unable to due to the patient¿s pain. The physician attributed the increase in seizure frequency and duration to the inability to increase device settings to therapeutic levels. Attempts for additional relevant information have been unsuccessful to date. The high impedance event was reported in manufacturer report #1644487-2013-00524.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
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 Key4789910
Report Number1644487-2015-04767
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/22/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/21/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date08/31/2014
Device MODEL Number103
Device LOT Number202210
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/22/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/28/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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