MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 303

Model Number 303-20

Device Problems Failure to Align (2522); Positioning Problem (3009)

Patient Problems Pain (1994); Hot Flashes/Flushes (2153); Numbness (2415)

Event Date 05/09/2014

Event Type  Injury  

Event Description

It was reported that the vns patient would at times experience numbness under her chin and hot flushes in her left arm after her device was programmed on during an office visit on (b)(6) 2014.The patient¿s device showed lead impedance within normal limits (impedance value ¿ 2304 ohms) at the time.The patient was seen on (b)(6) 2014 and reported having some pain in her left arm after her device settings were increased.The patient¿s device showed increased lead impedance but still within normal limits (impedance value ¿ 4649, 4622 and 4701 ohms).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 appears fully inserted into the generator connector block.The electrodes appeared to be placed in an abnormal arrangement as they do not align with the spine but rather perpendicular to the spine.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 reported events may be due to the abnormal placement of the electrodes.However, no definitive conclusions can be made.The patient was referred for surgery but no known surgical interventions have occurred to date.Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.X-rays reviewed by manufacturer, no gross lead discontinuities visualized but identified abnormal placement of electrodes.

• Brand Name: LEAD MODEL 303
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS INC; 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: 3899453
• MDR Text Key: 4545221
• Report Number: 1644487-2014-01608
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2017
• Device Model Number: 303-20
• Device Lot Number: 3613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 58 YR