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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 300

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CYBERONICS - HOUSTON LEAD MODEL 300 Back to Search Results
Model Number 300-30
Device Problems Corroded ; Fracture; Mechanical Problem
Event Date 06/01/2015
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

The patient's vns was returned to the manufacturer for an unknown reason. Follow-up with the physician's office showed the patient was explanted due to a lack of efficacy and because she wanted to be able to have mris. A battery life calculation was performed which showed the no anomalies and indicated the patient would have approximately 4. 3 years remaining until the neos = yes (near end of service) condition. The information available was only from (b)(6) 2011 through (b)(6) 2012. The programming history database was reviewed which showed no anomalies. The information available was from (b)(6) 2011 through (b)(6) 2012. Product analysis for the returned lead was completed. During analysis, a coil break was observed, along with abrasions on the inner and outer silicone tubes. Scanning electron microscopy (sem) was performed which identified the area as having extensive pitting which prevented the identification of the fracture type. Sem was then performed on the mating end of the broken coil and identified the area on three of the broken strands as being mechanically damaged with fine pitting which prevented the identification of the fracture type. The area of the remaining broken strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. Flat spots and pitting were observed on the coil¿s surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the coil shows characteristics typical of a lead discontinuity, which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching, or material dissolution. Additional follow-up with the physician's office showed that the patient was seen for a visit in (b)(6) 2015 and the device showed high impedance with a dcdc value of 7, which had increased from a previous value of 1. It was noted the patient's previous visit was in september of 2014 and the high impedance was believed to have occurred sometime between those dates. It was noted the patient's seizures had decreased after lacosamide was started and after the high impedance was first observed, indicating the patient did not benefit from the vns.

 
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Brand NameLEAD MODEL 300
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 Key6305667
Report Number1644487-2017-03143
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/06/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/06/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/13/2003
Device MODEL Number300-30
Device LOT Number4308
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/28/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/23/2017
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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