• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 1000 GENERATOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CYBERONICS - HOUSTON PULSE GEN MODEL 1000 GENERATOR Back to Search Results
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/18/2018
Event Type  Death  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported by the physician that the patient had passed away due to sudden unexpected death in epilepsy (sudep). The patient's mother indicated that the vns contributed to the patient's passing; however, the physician reported that was not the case. The physician indicated that the patient's death was not attributed to vns. The last system diagnostics known for the patient were within normal limits. The mother reported that on the day of the patient's death he had a slight seizure around 8 am and his heart stopped. The emt worked on him for several hours but he was eventually pronounced dead at 11 am. The patient's mother additionally reported that the patient's vns had been turned off for an mri a few weeks before the patient's passing and was turned on by a different neurologist. The mother reported that the son thought the neurologist had turned on the stimulation too high and wanted the generator explanted. She reported that the patient's generator would constantly turn on and off, and that it affected the patient's vocal cords. She reported that the patient's device was not helping him and that there was an increase in seizure frequency. She also reported that the patient had horrible heartburn and was agitated the day before he passed away. The patient's autopsy came back negative for any abnormal tests. The suspect product has not been received to date. No further relevant information has been received to date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 1000
Type of DeviceGENERATOR
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8242124
Report Number1644487-2019-00056
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 01/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/11/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number1000
Device LOT Number204232
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/18/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/18/2017
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: 01/11/2019 Patient Sequence Number: 1
-
-