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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 (2993)
Patient Problems Tachycardia (2095); Convulsion, Clonic (2222); Confusion/ Disorientation (2553)
Event Date 03/01/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient had an episode of increased heartrate and discoloration of his arm.After that episode, he was in and out of the hospital at least 3 times.During the admissions, he began developing memory loss and confusion.Between admissions, the patient had a "bad seizure" and mom swiped the magnet because "he looked dead." he had fever, nausea/vomiting, and mom drove him to the hospital.In the er, he was still nonresponsive but per the mother they treated him like a psychiatric case.The mother, however, wanted the vns checked as she was unsure the vns was working and was concerned that there was something else beyond psychiatric issues.When the patient's device was turned off for an mri, it was determined that the patient's vns was set to correct settings and was functioning normally.No further relevant information has been received to date.
 
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Brand Name
PULSE GEN MODEL 106
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
dana sprague
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key11792551
MDR Text Key250227768
Report Number1644487-2021-00631
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750061
UDI-Public05425025750061
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other
Type of Report Initial
Report Date 05/07/2021
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 Date01/10/2020
Device Model Number106
Device Lot Number204358
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 04/14/2021
Initial Date FDA Received05/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/30/2018
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) Hospitalization;
Patient Age19 YR
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