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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 Premature End-of-Life Indicator
Event Date 12/01/2018
Event Type  Malfunction  
Event Description

It was reported by the patient that she had severe pain on the right side of her brain that radiated down through her body into her legs. The patient reported everything twitched and that it was not a seizure. The patient continuously felt like her head was pounding and pain would not go away. The patient did not take medication and saw physician later in the day who stated battery had dropped. The patient stated her and the physician could not understand why her battery had dropped drastically and caused that pain. The patient stated that she stays away from any electronics that may cause accidental magnet stimulation and did not believe this to be the cause of the pain. The tablet data for the generator was received and reviewed by the manufacturer. No battery status indicator was flagged in the data available, which was from approximately half a year prior to the allegation. As no recent data is available, it was unable to be assessed whether the alleged premature depletion was present. A review of device history records revealed that the generator passed quality control inspection prior to distribution. The device was found to have been manufactured using the laser routing process. No additional 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 Key8268943
Report Number1644487-2019-00126
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 01/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/22/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/20/2017
Device MODEL Number106
Device LOT Number203452
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/28/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/19/2016
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: 01/22/2019 Patient Sequence Number: 1
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