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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 03/15/2006
Event Type  Injury  
Event Description

It was reported by the pt that she was having a lot of gastric reflux problems and thought it may be due to her vns. She also reported a pain in between her vagus nerve and esophagus. The pt did want the vns explanted as it had not been beneficial for her. The device had been turned off due to the pain, but the pain was still present when she eats. Furthermore, the pt claimed to have an irregular heartbeat, which she did not know if it was related to vns. All of the pt's problems supposedly began after she was implanted. Attempts for further info have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
ste 600
houston , TX 77058
2812287200
MDR Report Key2141185
Report Number1644487-2011-01391
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Consumer
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 05/23/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/22/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date08/31/2007
Device MODEL Number102
Device LOT Number014188
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received05/23/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2005
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: 06/22/2011 Patient Sequence Number: 1
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