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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 10/01/2014
Event Type  Injury  
Event Description

It was reported that the patient was coughing up blood and having difficulty swallowing for approximately the past two months. The patient has changed physicians and when the patient was first seen by the new physician the patient was bradycardic and hypotensive. The patient's brother reported that the patient underwent testing because it was thought the patient had lunch cancer from spitting up blood. No additional relevant information has been received to date.

 
Event Description

It was reported that the patient¿s dysphagia was related to vns therapy. The patient¿s arrhythmia did not occur while performing diagnostics or following a settings change. It was noted that the patient failed a swallow study on (b)(6) 2014.

 
Event Description

It was reported that the patient had a mini stroke in (b)(6) and has since been experiencing aspiration and severe dysphagia. The speech pathologist did not know if the events were related to vns. She was planning to use muscle stimulation on the patient¿s throat. Good faith attempts for additional relevant information have been unsuccessful to date.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 103
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 Key4377461
Report Number1644487-2015-03494
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 12/04/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/02/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2012
Device MODEL Number103
Device LOT Number3049
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/06/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/28/2011
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: 01/02/2015 Patient Sequence Number: 1
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