MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

Model Number 304-20

Device Problem Low impedance (2285)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2015

Event Type  malfunction  

Event Description

The patient was referred for a prophylactic generator replacement when it reported that low impedance had been observed for quite some time on the generator, the exact date of first observance was not known.X-rays had been performed and the results were reviewed by the physician.Since no lead discontinuity was observed by the physician he decided to leave the lead implanted and only replace the generator.After the new generator was implanted the low impedance continued to be observed.Further follow-up with the physician found the patient felt stimulation at higher settings and the patient's seizure condition were under good control.Additionally, the physician noted that the x-rays did not show any signs of a short circuit condition in the lead.Therefore the physician felt that it was reasonable to leave the system implanted and to only replace the generator when the battery expired.The x-rays have not been reviewed by the manufacturer to date.No additional relevant information has been received to date.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• 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 Key: 6176718
• MDR Text Key: 62861498
• Report Number: 1644487-2016-02866
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2015
• Device Model Number: 304-20
• Device Lot Number: 201709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 41 YR