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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106 LEAD

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CYBERONICS - HOUSTON PULSE GEN MODEL 106 LEAD Back to Search Results
Model Number 303-20
Device Problem Mechanical Problem
Event Date 09/15/2017
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported that a vns patient has had a recent change in behavior, becoming very agitated and feels like she is being shocked. Follow-up from the company representative who spoke to the physician provided that he thought it was due to the last increase in dose. He also said that the patient is very thin and you can feel the lead which he then said it might have felt like it was twisted but not sure. He referred the patient to the surgeon for a check of the lead. All diagnostics checked out fine. Further follow-up from the provider indicated that they found a wire that appeared to be kinked. The device was functioning with no errors and impedance was within normal limits. Additional relevant information has not been received to-date.

 
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Brand NamePULSE GEN MODEL 106
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 Key7019422
Report Number1644487-2017-04759
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 11/10/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/10/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number303-20
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/18/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/03/2015
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: 11/10/2017 Patient Sequence Number: 1
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