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

Model Number 300-20

Device Problems High impedance (1291); Unexpected Therapeutic Results (1631)

Patient Problems Seizures (2063); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 10/23/2014

Event Type  malfunction  

Event Description

It was reported that the patient was seen by the nurse practitioner due to an increase in seizure activity.It was reported that device diagnostics resulted in high impedance.The device output current was decreased from 2ma to 1.5ma.The patient was sent for x-rays.Further follow-up revealed that device diagnostics on (b)(6) 2014 were within normal limits.The patient underwent generator replacement on (b)(6) 2014 and post operative device diagnostics were within normal limits.It was reported that the increase in seizures is thought to be due to a loss of vns therapy.The seizures were not back to the patient's pre-vns baseline frequency.There were no external factors that are believed to have caused or contributed to the high impedance.Clinic notes dated (b)(6) 2014 note that device diagnostics showed high impedance.Surgical clinic notes dated (b)(6) 2014 note that the patient had been doing very well with decreased seizure frequency until more recently and that high impedance was observed by the neurologist.It was noted that device diagnostics were again performed which indicated high impedance (6475 ohms).It was noted that the patient will undergo lead replacement with possible generator replacement due to device compatibility.The device was programmed off.No known surgical interventions have been performed to date.

Event Description

It was reported that the patient underwent generator and lead replacement on (b)(6) 2014 due to lead discontinuity.The explanted generator and lead were received for analysis.Analysis is underway, but has not been completed to date.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death.

Manufacturer Narrative

Corrected data: this information was inadvertently left off of follow-up mfr.Report #02.

Event Description

Analysis of the lead was completed on 01/13/2015.A break was identified in the negative coil.Scanning electron microscopy images of the negative coil at the suspected torn end located at the 1st portion of the returned lead show that a stress-induced fracture (due to rotational forces) has occurred on the coil wires.Although not conclusive secondary fractures noted in the vicinity of the broken end suggest the stress-related primary fractures were most likely created during the explant procedure.Scanning electron microscopy images of the negative coil at the second portion show that pitting or electro-etching conditions have occurred at the coil end and at the area where a dark appearance was noted.Due to metal dissolution and surface contamination a conclusive determination of the fracture mechanism cannot be made.Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.Analysis of the generator was completed on 01/19/2015.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to a death or serious injury.

• Brand Name: BIPOL LEAD MODEL 300
• 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: 4319221
• MDR Text Key: 5245609
• Report Number: 1644487-2014-03251
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/10/2014

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: 06/30/2003
• Device Model Number: 300-20
• Device Lot Number: 3359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/21/2015
• Initial Date FDA Received: 12/10/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/07/2015; 01/20/2015; 01/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2001
• 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 Outcome(s): Required Intervention
• Patient Age: 16 YR