MAUDE Adverse Event Report: CYBERONICS BIPOL LEAD MODEL 300

Model Number 300-20

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

Patient Problem No Code Available (3191)

Event Date 02/03/2015

Event Type  malfunction  

Event Description

It was reported that a lead test resulted in high impedance during generator replacement surgery due to battery depletion on (b)(6) 2015.It was reported that a new lead test after surgery resulted in high impedance.The pulse generator was not enabled after surgery.It was later reported that high impedance had been found after generator replacement surgery.X-rays dated on (b)(6) 2015 were received and reviewed by the manufacturer.The generator appeared in a normal placement in the upper left chest.The filter feed-through wires appeared to be intact.The lead connector pin seemed to be fully inserted into the generator connector block.No sharp angles or lead breaks were visible.No obvious cause for the high impedance could be identified.An implant card was received which indicated that the lead impedance was correct upon the generator replacement, but the healthcare professional indicated that this was not correct.The healthcare professional further indicated that high impedance (> 10000 ohms) persisted the day after surgery.No known surgical interventions have occurred to date.

Manufacturer Narrative

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

• Brand Name: BIPOL LEAD MODEL 300
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS; 100 cyberonics blvd; houston TX 77058
• 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: 4552818
• MDR Text Key: 18066173
• Report Number: 1644487-2015-03980
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• 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: Physician
• Type of Report: Initial
• Report Date: 02/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2003
• Device Model Number: 300-20
• Device Lot Number: 4344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2001
• 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: 27 YR