MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem High impedance (1291)

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

Event Date 04/18/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed high impedance.X-rays dated (b)(6) 2014 were provided to the manufacturer for further review.The generator appears in the left chest in a normal placement.The filter feed-through wires appear to be intact.The lead connector pin cannot be confirmed to be fully inserted into the generator connector block due to the quality of the images provided.The electrodes appeared to be placed in normal arrangement.Part of the lead was behind the generator and could not be assessed.No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed.Based on the images provided, the cause of the high lead impedance remains unknown.No known surgical interventions have occurred to date.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.X-rays reviewed by manufacturer, no gross lead discontinuities visualized.Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative

Date of event; corrected data: additional information indicates that the event date was the date of generator implant.Brand name; corrected data: additional information indicates that the suspect device is the generator.Type of device, name; corrected data: additional information indicates that the suspect device is the generator.Model #, serial #, lot#, expiration date; corrected data: additional information indicates that the suspect device is the generator.Operator of device; corrected data: additional information indicates that the operator of the device was the health professional.Date of implant; corrected data: additional information indicates that the suspect device is the generator.Device manufacture date; corrected data: additional information indicates that the suspect device is the generator.

Event Description

Additional information was received stating that the vns patient underwent surgery on (b)(6) 2014.The surgeon reinserted the lead pin into the generator header and the high impedance resolved.However, the surgeon observed a "little bubble" on the silicone layer of the lead.It appeared that there was fluid ingress in the outer silicone layer of the lead.The surgeon elected to replace the patient's lead during the procedure.The explanting facility returned explanted device to the patient; therefore, no analysis can be performed.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 3995757
• MDR Text Key: 4820417
• Report Number: 1644487-2014-01986
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: 103
• Device Lot Number: 202496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2013
• 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: 12 YR