• 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 01/04/2019
Event Type  Injury  
Event Description

It was reported that the patient was in the er for bradycardia, syncope, and a possible heart blockage. The physician was questioning whether this was related to the vns. It was stated that the patient had been bradycardic ever since implant. A review of device history records revealed that the generator and lead passed quality control inspection prior to distribution. No additional relevant information has been received to date.

 
Event Description

Follow up with the physician's office revealed that it was believed that the cardiac symptoms were related to the vns as the arrhythmias did not return when the vns was programmed off. It was confirmed that the patient had a history of cardiac issues. Diagnostic results from a clinic visit few months prior were within normal limits.

 
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
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8764641
Report Number1644487-2019-01297
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/10/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/05/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number1000
Device LOT Number204704
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/24/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/15/2018
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: 07/05/2019 Patient Sequence Number: 1
-
-