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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 105 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Device Problem Premature End-of-Life Indicator
Event Date 11/01/2018
Event Type  Malfunction  
Event Description

It was reported by the patient that she felt that her depression was worsening. The patient was to follow-up with her physician in order to get the vns checked as she felt that the depression was a result of a low vns generator battery. Clinic notes were received by the manufacturer showing that the vns was pulse disabled, or programmed off due to the vbat being less than the end of service, or eos, threshold. The tablet data for the generator was received and reviewed by the manufacturer. The device was confirmed pulse disabled. The discrepancy between the diagaccum consumed value and the battery voltage on the date in the clinic notes provided is an indication that the battery was depleting faster than expected. It is unknown whether this is the result of an asic latch-up condition caused by exposure to electrocautery. A review of device history records revealed that the generator passed quality control inspection prior to distribution and was manufactured well before laser routing was utilized. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 105
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 Key8144303
Report Number1644487-2018-02248
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 02/14/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/07/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/23/2015
Device MODEL Number105
Device LOT Number202808
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/26/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/22/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/05/2014
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: 12/07/2018 Patient Sequence Number: 1
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