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U.S. Department of Health and Human Services

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

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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 12/17/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the patient was hospitalized due to difficulty swallowing. The patient has since been discharged and is doing better. The physician believed that the difficulty swallowing was most likely the result of anesthesia and intubation during vns surgery. Clinic notes were received dated 12/31/2018. After the patient¿s generator was replaced, the patient was admitted to the hospital due to vomiting and gagging and remained hospitalized for 11 days. The patient had an increase in seizures and severe constipation as well. Per the physician's assessment, the patient had a similar response to t&a so it is unknown if this was due to anesthesia or due to swelling in the neck following surgery. Attempts were made to the physician for more information. Per the physician, the patient's increase in seizures was believed to be due to missing medications due to vomiting. The increase in seizures was above pre vns baseline. The cause of the vomiting was unknown if it was due to constipation/discomfort from vns surgery/presumed neck swelling. The anesthesia and medications may have also contributed. The vomiting started the day after vns surgery. The patient had improved as quickly as it began. The constipation was a chronic condition that was made worse by surgery, likely due to anesthesia and was unrelated to the vns. The patient's swelling was only presumed based on symptoms. The swelling of the neck was from the vns surgery and began on the day of the vns surgery. The device history records were reviewed for the generator and lead. They passed all specifications prior to distribution. No additional information has been received to date.

 
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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 Key8272311
Report Number1644487-2019-00114
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/23/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/23/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1000
Device LOT Number204625
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Device Age1 mo
Event Location Other
Date Manufacturer Received12/31/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/10/2018
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: 01/23/2019 Patient Sequence Number: 1
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