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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/05/2007
Event Type  Injury  
Event Description

It was reported that a patient's device was turned off "10 years ago" as it did not help her, but actually increased her seizures. The patient also reported feeling discomfort from the device. Review of the manufacturer's programming history found no device diagnostics and noted that the device was turned off in 2007 after being titrated up to output current of 1. 25ma normal mode stimulation. No anomalies were noted. No further relevant information was received to date.

 
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Brand NamePULSE GEN MODEL 102
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 Key8394341
Report Number1644487-2019-00425
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 03/06/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/06/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/15/2007
Device MODEL Number102
Device LOT Number014911
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/11/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/23/2006
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: 03/06/2019 Patient Sequence Number: 1
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