MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL UNKNOWN

Device Problems High impedance (1291); Battery Problem (2885)

Patient Problem No Code Available (3191)

Event Date 10/30/2014

Event Type  malfunction  

Event Description

It was reported that during generator replacement surgery due to end of service, the vns patient¿s replacement generator was connected with the existing lead and diagnostic results revealed high impedance.The surgeon reinserted the lead pin and subsequent tests showed lead impedance within normal limits.The procedure was completed but the patient device was tested again during recovery and high impedance was again observed.No tests could be performed prior to the procedure due to end of service condition.X-rays 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 appears fully inserted into the generator connector block.The electrodes appeared to be placed in normal arrangement.Portions of the lead were unable to be assessed due to the quality of the images provided.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 for the high impedance have occurred to date.

Event Description

The arrangement of the electrodes could not be assessed.Additional information was received stating that the vns patient¿s device should lead impedance within normal limits (impedance value ¿ 2543 ohms) during an office visit prior to generator replacement on (b)(6) 2014.Patient manipulation or trauma is not believed to have caused or contributed to the high impedance.The patient¿s device was disabled following the high impedance observation.

Event Description

It was reported that lead revision surgery was planned.It was later confirmed that the intervention was completed on 02/05/2015.The explanted lead has not been returned 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

Describe event or problem; corrected data: the previously submitted mdr inadvertently stated that the electrodes were in correct arrangement when actually the arrangement of the electrodes could not be assessed.

• Brand Name: LEAD MODEL UNKNOWN
• Type of Device: LEAD
• 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: 4278097
• MDR Text Key: 5011127
• Report Number: 1644487-2014-03142
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 34 YR