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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 10/31/2016
Event Type  Death  
Manufacturer Narrative

 
Event Description

It was reported on (b)(6) 2016 that the patient passed away and it was stated to be probable sudep. An obituary search showed that the patient died on (b)(6) 2016. The patient was buried with the device therefore it is not available for return. It was also indicated by the funeral home that the patient died of cardiac arrest. No additional relevant information has been received to date.

 
Event Description

It was reported that the patient passed away from aspiration. The patient had a history of obstructive sleep apnea. It was stated that this was not related to vns therapy and vns therapy helped reduce seizure frequency.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
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 Key6156291
Report Number1644487-2016-02817
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/22/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/08/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2013
Device MODEL Number102
Device LOT Number2934
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/20/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/20/2011
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: 12/08/2016 Patient Sequence Number: 1
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