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

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 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, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/07/2017
Event Type  Injury  
Manufacturer Narrative

 
Event Description

A patient was admitted to the hospital after experiencing sinus bradycardia, tachycardia, and syncope. The patient's family doctor, who did not manage the patient's vns, did not believe that the arrhythmias and syncope were related to vns; however, the medical staff at the admitting hospital wanted to monitor the patient to understand whether there was a relationship between the arrhythmias and syncope to vns. Both the medical staff and family doctor believed that the syncope was potentially related to the bradycardia as it occurred when the position rose to a standing position after sitting down. Monitoring determined that the patient's bradycardia was constant during both vns stimulation on and off times. According to the nurse at the admitting hospital, the patient had previously been admitted to another hospital for nonsustained ventricular tachycardia three years prior to the recent arrhythmias. The patient's resting heart rate was reportedly 54 beats per minute. Device diagnostics were performed and returned results within the normal limits. Additionally, the patient reported that her vns settings had not been changed by her prescribing psychiatrist in over 5 years. The attending nurse later reported that she believed that the patient's blood pressure medication was adjusted during the hospital, but she did not know of the cause of the arrhythmias and syncope or their relation to vns. No further relevant information has been provided to date.

 
Event Description

Clinic notes were received from the patient's er visit that indicated that the patient was admitted to the hospital after experiencing cardiac-related chest pain that was unrelieved by nitroglycerin. The patient's resting heart rate on intake was 51 beats per minute, and her blood pressure was 104/70, which was indicated as within the normal limits. The chest pain radiated to the patient's left arm and shoulder. The patient was noted to be bradycardic. X-rays taken on the day of admission showed cardiomegaly, but there was no evidence of that condition observed in x-rays the following day. Per the clinic notes, the vns was interrogated and observed to be at neos = no with diagnostic results within the normal limits. The vns was disabled via magnet inhibition while the medical staff attempted to discern the relation of the vns to the patient's bradycardia. The medical staff later assessed that the chest and left arm pain were caused by the patient's beta blockers. The patient's medications were adjusted several times during the hospital stay. The chest pain appeared to resolve after a change to new medication, and the patient was discharged from the hospital in stable condition. No additional relevant information has been received to date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6685193
Report Number1644487-2017-04086
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 09/01/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/03/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2007
Device MODEL Number102
Device LOT Number014188
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/07/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/10/2005
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: 07/03/2017 Patient Sequence Number: 1
-
-