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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 05/03/2010
Event Type  Injury  
Event Description

A vns pt called and reported that she had been at the hospital on (b) (6) 2010 because the device had been choking her. She had been admitted to the hospital on (b) (6) 2010 because after using her magnet, she felt like her heart was racing. She reported, the hospital treated her like a cardiac pt because they thought she was having a heart attack and believed the vns was the cause. Additionally, she reported that after her initial implant she was unable to eat. Good faith attempts thus far 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 Key1716183
Report Number1644487-2010-01374
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 05/13/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/09/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2010
Device MODEL Number103
Device LOT Number2561
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received05/13/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2010
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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