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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 01/01/2014
Event Type  Injury  
Event Description

The patient reported that she has experienced a recent exacerbation of cardiac arrhythmia. The patient attributes this to vns and reported that she is on low settings. The patient indicated that she has a history of arrhythmia for which she is followed by a physician. The patient reported that experienced five straight days of severe arrhythmia, but that it is not as bad anymore. The patient reported that she was originally diagnosed with premature ventricular contraction two to three years ago. The patient indicated that she had a feeling vns therapy affected it. Attempts to obtain additional relevant information have been unsuccessful to date.

 
Event Description

Additional information was received stating that the vns patient was briefly hospitalized in mid-(b)(6) 2014 after experiencing a blackout. The treating physicians attributed the blackout to either bradycardia, cva or a clotting disorder. The patient¿s description of the event suggested that the event was not arrhythmia but an absence seizure. The patient was last seen by her neurologist on (b)(6) 2014 so the neurologist is unable to provide any feedback regarding the event. The patient has not been seen by a medical professional to date.

 
Manufacturer Narrative

Outcomes attributed to adverse event, corrected data: additional information indicates that the patient was hospitalized.

 
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Brand NamePULSE GEN MODEL 105
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3688946
Report Number1644487-2014-00725
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 02/18/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/19/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2014
Device MODEL Number105
Device LOT Number202019
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received07/21/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/07/2012
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: 03/19/2014 Patient Sequence Number: 1
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