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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL UNK LEAD

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CYBERONICS - HOUSTON PULSE GEN MODEL UNK LEAD Back to Search Results
Event Date 01/02/2017
Event Type  Injury  
Manufacturer Narrative

 
Event Description

An article was received that reported multiple adverse events and a malfunction. The current report captures the adverse events associated with the lead. Mfr. Report # 1644487-2017-04155 captures the malfunction reported by the article. Mfr. Report # 1644487-2017-04153 captures adverse events associated with the generator. There was one intraoperative event associated with the lead. This patient experienced mild oozing from the jugular vein that was controlled by bipolar cautery. One patient had a prominent electrode in his neck which presented as pain and discomfort within a week post operatively. Two other patient's also had pain due to prominent electrodes, but these were associated with trauma to the vns area. These three patient's neck wounds were revised and the electrodes repositioned. The article later describes these electrodes as being "dislodged. " no further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL UNK
Type of DeviceLEAD
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 Key6723266
Report Number1644487-2017-04154
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Report Date 07/18/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/18/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/19/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 07/18/2017 Patient Sequence Number: 1
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