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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 02/18/2011
Event Type  Injury  
Event Description

It was reported by a vns patient that she was having painful stimulation in her neck and chest since her stress test on (b)(6) 2011. The patient said she was also having a loss of appetite with headaches during the stimulation. She alleged that her device was failing. However, her psychiatrist performed system and normal diagnostics which showed the device was within normal limits, dcdc=2, eos=no and dcdc=5, eos=no, respectively. The patient's current settings were 2/20/500/30/5; however, the doctor decreased the output current to 1. 75 ma. The psychiatrist did not want to disable the device because the patient was receiving efficacy. She called manufacturer again on (b)(6) 2011 and stated that her device was failing. She wanted her device removed. She was told to contact her physician; however, she stated that the physician will no longer see her and threatened to commit suicide over the phone. She was offered to be transferred to crisis help line or call 911 which she declined. Manufacturer contacted the treating physician and he stated that patient has had suicidal ideations before but has never followed through. The treating psychiatrist stated that patient's depression and threats of self harm had increased over the last month. The physician didn't feel the patient's issues were related to the vns therapy or the result of a malfunction, just that her disease condition was so severe that it didn't respond to the vns therapy.

Event Description

Additional information was received on (b)(6) 2012, when it was reported that the patient would like to have her vns tested. The patient was dismissed by her last physician and none of the other physicians were willing to see her. The patient was given contact information for additional physicians in her area.

Event Description

Additional information was received stating that the vns patient had not felt stimulation from her device for quite some time and wants to have the device replaced or removed. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.

Event Description

Additional information was received stating that the vns patient underwent generator replacement surgery on (b)(6) 2014 due to battery depletion. The explanted generator has been returned to the manufacturer where analysis is currently underway.

Event Description

Analysis of the returned generator was completed. The generator could not be interrogated at two orientations, but was successfully interrogated once the programming wand was repositioned. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. Monitoring of the device output current showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. There were no anomalies found with the pulse generator. The generator performed according to functional specifications.

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Manufacturer (Section D)
houston TX 7705 8
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key2055651
Report Number1644487-2011-00784
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Other,Consumer,Health Professional,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/16/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/12/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2008
Device MODEL Number102
Device LOT Number015709
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/19/2014
Date Manufacturer Received10/24/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 04/12/2011 Patient Sequence Number: 1