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U.S. Department of Health and Human Services

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

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CYBERONICS - HOUSTON PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/06/2011
Event Type  Injury  
Event Description

It was reported by the patient¿s mother that her son has more seizures when his battery reaches 25%, and that the neurologist increases the keppra dose to counteract the seizures. The patient had generator replacements in 2007, 2011, 2015, and is scheduled for replacement currently. The increase in seizures in 2007 is reported under mfr. Report # 1644487-2007-01077, the increase in seizures in 2015 is reported under mfr. Report # 1644487-2019-00636, and the increase in seizures in 2019 is reported under mfr. Report # 1644487-2019-00652. This report concerns the increase in seizures in 2011 and subsequent generator replacement. The generator replacement was initially reported to be prophylactic. The explanted generator was later received by the manufacturer and an analysis was performed. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Additionally, the generator¿s header was found to be detached, but based on the observed tool marks on the pulse generator case it is very likely that this occurred during or after the explant procedure. Other than the header anomaly, there were no performance or any other type of adverse conditions found with the pulse generator. No additional or relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 102R
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 Key8491278
Report Number1644487-2019-00642
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 04/08/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/23/2008
Device MODEL Number102R
Device LOT Number016522
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/17/2012
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/13/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/17/2007
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: 04/08/2019 Patient Sequence Number: 1
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