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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/01/2019
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that the patient experienced very low heart rates (reportedly in the 20s) to very high heart rates (reportedly in the 200s). The patient reportedly taped the magnet over the generator to inhibit stimulation which resolved the event until the magnet fell off. After this, the patient experienced a low heart rate and felt as if he would pass out. The neurologist reported system diagnostics results were within normal limits and the patient was at moderate settings. The physician was concerned that the lead was ¿tethered incorrectly¿ and requested x-rays be performed. The patient was referred for surgery to inspect the leaf. Ap neck and lateral chest x-rays of the patient were reviewed. The scope of the images did not include the generator and therefore the placement of the generator, the intactness of the feedthru wires, and complete lead pin insertion could not be assessed. The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest. A strain relief bend is present per labeling but no strain relief loop is present. Two tie downs are present with the initial tie down securing the first relief bend, and the second tie down securing a second relief bend. It could not be assessed if the lead was routed behind the generator due to the scope of the image. No sharp angles were identified in the visible portions of the lead. No gross discontinuities were identified in the visible portions of the lead. Additionally, the electrodes appeared to be placed normally on the patient¿s nerve. No obvious cause of the patient¿s heart fluctuations could be identified from the available images. A review of the available images did not reveal any anomalies that indicated device malfunction. Follow up with the patient's neurosurgeon determined that the patient had also passed out multiple times due to the low heart rate. Additionally, the patient's vns was disabled due to the arrhythmia after which the heart issues resolved. The physician also reported that there was no known changes in the patient's vns therapy prior to the heart issues which would have contributed. The patient has been referred to a local electro physiologist for additional evaluation. No relevant surgical intervention is known to have occurred to date. No additional or relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 106
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 Key8443672
Report Number1644487-2019-00565
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 03/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/22/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/22/2018
Device MODEL Number106
Device LOT Number203782
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/25/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/05/2016
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: 03/22/2019 Patient Sequence Number: 1
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