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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 09/01/2010
Event Type  Injury  
Event Description

It was initially reported by the physician that the patient went to the er due to choking, shortness of breath, chest pain and an accelerated heart rate. The er physician placed the magnet over the device and the events resolved. Patient visited his treating physician after that and his device was disabled and patient was referred for removal surgery. Physician stated that the patient had no history of heart problems. Physician stated that the patient was set at 01/30/1000/60/180. Additional information received stated that the patient underwent a vns explant surgery. Explanted products were returned to manufacturer for analysis. Analysis is currently in progress for the explanted products.

 
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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 Key1888980
Report Number1644487-2010-02373
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 09/21/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/21/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date08/31/2010
Device MODEL Number102
Device LOT Number014897
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer10/20/2010
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/21/2010
Was Device Evaluated By Manufacturer? No
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: 10/21/2010 Patient Sequence Number: 1
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