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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 104 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 104 GENERATOR Back to Search Results
Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/01/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

The patient's mother reported that the patient had been in the hospital due to vomiting, gagging, pain under each arm, hiccups and hypotension. The patient's vns was disabled for 24 hours in the hospital. When the device was off, there was no gagging and vomiting. When it was turned back on, the gagging and vomiting was less. The patient had reportedly lost 5 pounds since the vomiting started. After a full gi work-up, nothing but gastric irritation was found. The treating physicians in the hospital didn't think that the vns was the cause, but they wanted to further investigate and confirm this. The patient's mother reported that the treating physician said that her daughter was using the magnet too often. The patient was in the hospital for approximately 2 weeks. The patient's mother also reported that the patient was now experiencing pain at the generator site. When the patient saw another doctor for follow-up, he did believe that the patient's vomiting, nausea, pain at chest, under arms, hypotension and hiccups were related to the vns stimulation. He indicated that the patient's output current was too high at 2. 75 ma, so he decreased it to 2. 5 ma due to the vomiting and hiccups. No device error was noted by the physician. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 104
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8036490
Report Number1644487-2018-01980
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 11/04/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/04/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/15/2017
Device MODEL Number104
Device LOT Number203398
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/10/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/22/2015
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: 11/04/2018 Patient Sequence Number: 1
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