MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problem High impedance (1291)

Patient Problem Seizures (2063)

Event Date 07/31/2015

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported by the physician that high impedance was observed on the patient's vns device during an office visit on (b)(6) 2015.It was also reported the patient began experiencing an increase in seizures at the end of (b)(6).It was stated the physician believes the recent increase in seizures is due to the high impedance observed.It was noted the physician will keep the device programmed on for now.No known surgical interventions have occurred to date.

Event Description

It was reported the patient's surgery was scheduled for (b)(6) 2015.The replacement surgery was completed on (b)(6) 2015.It was reported the physician believed the anchor tether came off the nerve and he elected to replace the lead.The vns generator was replaced prophylactically.Both the vns generator and the lead received by the manufacturer.Product analysis is expected but has not been completed to date.No additional relevant information has been received to date.

Manufacturer Narrative

If explanted, give date; corrected data: this information was inadvertently left off of supplemental #01 mfr.Report.Device available for evaluation; corrected data: this information was inadvertently left off of supplemental #01 mfr.Report.

Event Description

Product analysis for the returned generator was completed.The end of service warning message was verified and found to be associated with the output being disabled by the vns generator, burn marks were observed on the vns generator which indicated the generator may have been exposed to electro-cautery during explant.The vns generator was reset in order to allow for subsequent testing.It was found using the downloaded data from the generator that the date of the impedance increase was 05/04/2015.Electrical tests were performed on the vns generator and the results demonstrate that accurate resistance measurements were obtained in all instances.The device output signal was monitored for more than 24-hours while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the vns generator current for the entire monitoring period.The electrical evaluation showed that the vns generator performed according to functional specifications.Product analysis for the returned lead was completed.It should be noted the electrodes were not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product.Visual analysis showed a portion of the lead assembly appeared to be twisted and knotted together.These findings are consistent with patient manipulation/rotation of the device while it was implanted (twiddler).The abraded opening found on the outer silicone tubing and the cut ends that were made during the explant process most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.For the observed inner remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explant process.

• Brand Name: LEAD MODEL 304
• 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: 5113453
• MDR Text Key: 27254391
• Report Number: 1644487-2015-05969
• 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: 09/23/2015

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: 04/30/2016
• Device Model Number: 304-20
• Device Lot Number: 3322
• 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: 09/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2012
• 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: 15 YR