MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

Model Number 300-20

Device Problems High impedance (1291); Material Separation (1562)

Patient Problems Pain (1994); Seizures (2063)

Event Date 08/25/2015

Event Type  malfunction  

Event Description

A device check on a patient's device revealed high impedance and a dc dc value of 4.The patient was reported to have an increase in seizures but it could not be determined if they were due to the high impedance, the age of the implanted generator or other factors.The patient was sent for x-rays which were not provided to the manufacturer for review.The physician elected to leave vns stimulation turned on since the patient was not experiencing any pain with stimulation and the patient was scheduled for revision surgery.During the revision surgery it was observed that the generator header had detached from the generator casing.The lead was disconnected from the header and the generator and lead were each explanted and replaced.Lead impedance with the new generator and lead was normal, 1402 ohms.No impedance testing of the explanted lead was performed.It is unknown if patient manipulation or trauma contributed to the header separation from the casing.It was reported that the patient is in a wheelchair and is lifted in and out of it frequently, however, the patient has not been involved in any accident or falls.It is unknown if the pre-surgical x-rays indicated evidence of the header separation.The physician was unable to determine the exact date of the increased seizures or if the seizure frequency was above or below the patient's pre-vns seizure rate.The patient's family stated, "it could have been more." the explanted generator and lead have not been received by the manufacturer for product analysis to date.

Manufacturer Narrative

The initial mdr report should have indicated "not returned to mfr.".

Event Description

The physician stated there were no obvious pulse generator header issues observed on pre-surgical x-rays.The explanted pulse generator and lead have been received by the manufacturer and are currently undergoing product analysis.

Event Description

Based on the observed tool marks on the generator case and the condition of the header and casing in the detachment area, it is very likely that the reported header detachment occurred during the explant procedure.There was no evidence of dried body fluid or corrosion on the header or can in the detachment area.In order to test electrical function of the device a window was cut in the casing to facilitate output connections, however, an internal component was inadvertently damaged during the cutting of the window.After the component was replaced with a known good component, device testing was completed and the device was found to be operating properly according to all functional specifications.The lead assembly was returned in multiple portions, however, the electrodes and tie downs were not returned and therefore a complete evaluation could not be performed on the entire lead product.Abraded openings due to wear and incision marks were identified in multiple locations of the returned lead segments.Dried remnants of what appeared to have once been body fluids were observed inside the outer silicone tubing and likely entered via the cut ends of the lead segments.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portions were performed during the visual analysis and no discontinuities were identified.Except for abraded openings in the outer tubing, there were no observed product related issues with the returned lead portions.Based on product analysis of the returned pulse generator and lead it is likely that the reported high lead impedance was due to a lead fracture in a segment of the lead which was not returned to the manufacturer for product analysis.

• Brand Name: BIPOL LEAD MODEL 300
• 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: 5097678
• MDR Text Key: 26789135
• Report Number: 1644487-2015-05838
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2003
• Device Model Number: 300-20
• Device Lot Number: 4813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2010
• 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: 16 YR