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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 12/01/2010
Event Type  Injury  
Event Description

On (b)(6) 2013 the physician reported that the patient had gastroparesis and laryngeal difficulty. Per the physician, the patient¿s entire vns system was removed in (b)(6) 2013 with nothing in the operative note indicating nerve damage.

 
Manufacturer Narrative

This device was implanted to treat fibromyalgia which is an unapproved indication.

 
Event Description

On (b)(6) 2013, the patient reported that she has been having very bad digestion issues and difficulties swallowing since (b)(6) 2010. She stated that both issues started around the same time and said she has been to many specialists and physicians for the issue. The patient described the difficulty swallowing as "her food won't go down"; and confirmed that she was not vomiting her food back up, but was having a difficult time getting it to her stomach. Per the patient, solid foods will not digest at all and only liquids go down, but they go down very slowly. The patient stated that she has had many tests performed and has tried several different diets (e. G. The gluten-free diet, sugar free-diet, and dairy-free diet); however, nothing has worked and there has been no improvement. The patient explained that she has been diagnosed with gastroparesis and stated that several physicians believe her vagus nerve has been damaged. Per the patient, her physicians have stated that the vns device has caused nerve damage to her vagus nerve which has caused her to stop digesting food to her stomach. The patient's device stimulates for 30 seconds every 3 minutes, but the difficulty swallowing and digestion problems occur constantly and not just with stimulation. Per the physician's suggestion, the patient's device was turned off on (b)(6) 2013. Additionally, the patient stated that she has gained weight since (b)(6) 2012 as a result of the various diets she has been placed on. The patient stated that since this time she experiences shortness of breath with exertion that occurs all the time and not just with stimulation. Secondly, the patient began experiencing pain under her right rib which started when she gained weight in (b)(6) 2012. The pain was described as a constant pain that has gotten worse over time. This pain gets worse when the patient tries to eat or drink anything. At the time of this report, the patient stated that she had only had her vns device programmed off for a couple hours, but the pain has already lessened, though it was still present. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

 
Manufacturer Narrative

 
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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 Key3096041
Report Number1644487-2013-01256
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup,Followup
Report Date 04/09/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/07/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/04/2008
Device MODEL Number102
Device LOT Number016030
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received01/03/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/11/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/07/2013 Patient Sequence Number: 1
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