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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL 102R GENERATOR

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CYBERONICS PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Event Date 02/01/2015
Event Type  Injury  
Event Description

It was reported that a vns patient had vagal episodes from (b)(6) 2015 and persisted for 6 months. The device parameters were not changed. It was reported that during that period, the patient was in a clinic study (trial) from (b)(6) 2015. But due to high discomfort, she stopped it in (b)(6) 2015. It was reported that those discomforts included especially dizziness with nausea, sometimes accompanied by blurred vision and pallor, without loss of consciousness. It was reported that when a cardiologist saw the patient in (b)(6) 2015 for a clinic examination / ecg / abpm, the patient showed a sudden hypotension (70-80 systolic) without symptoms reported above. The patient was again seen by the cardiologist in (b)(6) 2015, who indicated that everything was fine. It was reported that the patient was initially implanted with vns in 2002, and then replaced in 2010. No patient adverse events were reported during that period before (b)(6) 2015. Review of manufacturing records of the generator confirmed all quality tests were passed prior to distribution. No additional relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 102R
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS
100 cyberonics blvd
houston TX 77058
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 Key5245961
Report Number1644487-2015-06474
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 10/28/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/24/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2010
Device MODEL Number102R
Device LOT Number2258
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/28/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/14/2009
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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