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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
Event Date 05/13/2013
Event Type  Injury  
Manufacturer Narrative

 
Event Description

Medwatch report mw5061274 was received by the manufacturer. The patient reported the following: "the last surgery i had was to insert a vagus nerve stimulator, vns made by cyberonics, this also became infected and i had yet another surgery and infection. They had to redo the surgery on my right chest instead of my left. The specific company for the vns was made by cyberonics with generator (b)(4). After this surgery i had to stay one night in the hospital. " mfr. Report# 1644487-2013-01470 reports an infection that occurred for the patient in (b)(6) 2012 on her right chest. The patient had generator replacement surgery on (b)(6) 2013 and it is unclear if she is stating in this report that replacement surgery led to infection. Attempts for additional information have been made, but no additional relevant information has been 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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key5685677
Report Number1644487-2016-01151
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation PATIENT
Report Date 05/02/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/27/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/09/2014
Device MODEL Number102
Device LOT Number3359
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/02/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/15/2012
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: 05/27/2016 Patient Sequence Number: 1
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