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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 06/01/2011
Event Type  Injury  
Event Description

It was reported by a physician's office that the pt was complaining of chest pain, coughing, and pain in her right arm that started approx two weeks prior. The pt had been to the er and the physicians ruled out "other issues" and told the pt that the symptoms "must be the vns. " the pt was at very low settings and could not tolerate any higher programming. The pt swiped her magnet and had significant cough and tightening of her chest. Also, the pt was unable to tolerate the system diagnostic testing parameters to test device function. The device was disabled to see if the issue resolved. Also, the pt is not currently taking any different medications than in the past. 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 Key2201826
Report Number1644487-2011-01766
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 07/07/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/05/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2011
Device MODEL Number102
Device LOT Number2620
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/07/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2010
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: 08/05/2011 Patient Sequence Number: 1
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