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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 07/01/2010
Event Type  Injury  
Event Description

It was reported that the vns patient had experienced a stabbing pain in his left and right chest walls and was admitted to the hospital. The pt had a cardiology consult during which his vns was disabled. When stimulation was re-enabled, the pt's heart rate increased to 120 bpm. The physician stated that these symptoms were intermittent and not consistent with stimulation. Attempts for further 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 Key2039453
Report Number1644487-2011-00679
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/01/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/31/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2011
Device MODEL Number103
Device LOT Number201043
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/01/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2009
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: 03/31/2011 Patient Sequence Number: 1
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