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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103

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CYBERONICS, INC. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 12/31/2010
Event Type  Injury  
Event Description

It was initially reported that the pt has been experiencing chest pain and a feeling that the generator was moving since implant especially when taking in a breath. Pt had cardiac arrest twice in may and was in the icu at the time of the initial report. The generator was disabled and the pain was reported to have stopped. Add'l info was received from the physician's office that indicated that the pt was taken to the er after going into cardiac arrest where she was resituated and placed on a ventilator. When the pt was removed from the ventilator she would go back into cardiac arrest. It was indicated that the pt has been complaining of pain in the chest, which was described as both an irritation and supposed heart palpitations with vomiting. When the pt had a work up by the cardiologist there were no apparent issues. It is not clear to the physician if the events are in fact related to the device or psychosomatic. The pt is anorexic so it is unclear what effect that has had on the cardiac issues that pt has been experiencing. It is unk what the plan is or if interventions will be taken. The pt's mother wants vns removed. Good faith attempts for more info have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
ste 600
houston , TX 77058
2812287200
MDR Report Key2141191
Report Number1644487-2011-01403
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation
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 Date08/31/2012
Device MODEL Number103
Device LOT Number2767
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/23/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2010
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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