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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102; GENERATOR
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CYBERONICS - HOUSTON PULSE GEN MODEL 102; GENERATOR Back to Search Results
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 12/07/2020
Event Type  Death  
Event Description
It was reported the patient had passed away from sudep.It was noted that the death date was (b)(6) 2020.Per the physician, the official cause was of death was sudep and unrelated to vns.No additional relevant information has been received to date.
 
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Brand Name
PULSE GEN MODEL 102
Type of Device
GENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
rachel kohn
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key11057805
MDR Text Key223206047
Report Number1644487-2020-01739
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 12/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date04/18/2016
Device Model Number102
Device Lot Number202972
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 12/07/2020
Initial Date FDA Received12/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/18/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age14 YR
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