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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

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CYBERONICS - HOUSTON LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problem Fracture
Event Date 06/01/2019
Event Type  Malfunction  
Event Description

It was reported by the sales rep that the patient reported increase chest pain and was referred to see the surgeon. X-rays were sent in for prompt review. The x-rays were reviewed and the generator placement was determined in the left chest. Based on the scope of the image, the feed through wires were intact and the pin could be visualized passed the second connector pin per the scope and angle of the image. The lead was visualized in the chest and neck. The strain relief bend could be visualized, however due to the scope and quality of the image it could not be determined is a strain relief loop was present. Two tie downs were present however based on the scope and quality of the image it could not be determined if they were placed per labeling. The lead did not appear to be routed behind the generator; however this could not be properly assessed due to the quality of the image. The lead wires at the connector pin appeared to be intact but the lead appear to be twisted sharply near rib 2. The lead was assessed for fractures and no gross fractures or discontinuities were noted. Based on the x-rays received, and the quality and scope of the images, the cause for the chest pain could not be determined at this time. Information was later received from the physician's office indicating that the patient's pain began around june around vns site but is not constant. The cause of the pain was indicated to be unknown. It was indicated that at that time there was no plan for intervention to be taken and the patient would continue to be monitored and follow-up with neurosurgery as needed if pain persists. An implant and warranty card was later received indicating the patient received a full revision due to a lead fracture. Per the surgeon, the patient complained of shocking sensations but there was no note of high lead impedance. The facility the revision took place does not return explants, therefore the explanted product is not available for product analysis. No additional relevant information has been received to date.

 
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Brand NameLEAD MODEL 302
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
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key9128897
Report Number1644487-2019-01887
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 09/27/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/27/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/07/2012
Device MODEL Number302-20
Device LOT Number201071
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/03/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/20/2009
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: 09/27/2019 Patient Sequence Number: 1
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