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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 11/21/2006
Event Type  Malfunction  
Event Description

It was reported that a vns patient stated she developed a variety of neurological symptoms as a result of a device that she felt was broken resulting in pain and other issues. Per the patient, the neurologist she saw attributes all her symptoms to the device and advised her to have it explanted. On (b)(6) 2011, it was reported that the patient was complaining of pain even after the physician instructed her to place the magnet over the generator to temporarily inhibit stimulation. (b)(4) attempts to obtain additional information have been unsuccessful to date.

 
Event Description

On (b)(4) 2012, it was reported that this vns patient wanted her device explanted. No additional information was provided. Surgery is likely, but has not occurred.

 
Event Description

On (b)(6) 2013, it was reported that this patient wanted her device removed due to choking, occasional stuttering, and memory problems that the patient attributes to vns. The patient also felt the device did not help with depression. No additional information was available. Surgery is likely but has not taken place.

 
Event Description

The patient was seen on (b)(6) 2013, and clinic notes dated (b)(6) 2013 were received. The notes indicated that the patient had a previous medical history of depression/anxiety, irritable bowel syndrome, fibromyalgia, and scoliosis. The patient's depression was initiated by a familial death. The patient attributes multiple problems to her vns, including a sensation of spark in her left occipital region, occasional choking sensation, stuttering speech, and memory problems. The patient also reports an occasional left-sided headache, occasional parethesias on the left side of her neck, weakness in her right hand, and balance problems. The patient was seen on (b)(6) 2013. Diagnostics were run and were within normal limits. Settings were provided.

 
Event Description

Additional information was received stating that the vns patient was seeking to have her device explanted. The patient reported experiencing memory loss and losing her sense of direction. No known interventions have occurred to date.

 
Event Description

Additional information received from the physician revealed that the neurological issues the patient reported were mainly pain however the patient's chart was not available for him to confirm. The pain was not isolated to device stimulation. The physician did not have any additional information to provide.

 
Event Description

Additional information was received on (b)(4) 2012, when the patient reported that she was experiencing choking, burning at the top of the generator, memory loss, "zapping" on the left side of neck and back of her head and that she is not able to eat food properly. When she tried to disable the device using her magnet, the symptoms did not resolve. She stated that her settings were lowered however she is still having problems. The patient stated that she now has scoliosis and is on disability due to her issues with vns. Good faith attempts to obtain additional information from the patient's physician have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key2405008
Report Number1644487-2012-00056
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/13/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/09/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/09/2007
Device MODEL Number102
Device LOT NumberASKU
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/08/2014
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

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