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

Model Number 300-20

Device Problems Detachment Of Device Component (1104); Corroded (1131); Device Expiration Issue (1216); Fluid/Blood Leak (1250); Fracture (1260); High impedance (1291)

Patient Problems Seizures (2063); Seizures, Focal Motor (2064)

Event Date 04/01/2016

Event Type  malfunction  

Event Description

The mdr with the manufacturing number 1644487-2016-02697 houses the report of the header becoming detached from the patient's generator.Information was received which indicated that high impedance was seen on the patient's generator during a system diagnostic on (b)(6) 2016.The patient had been experiencing a change in seizure pattern and increase in the frequency of seizures since (b)(6) 2016.The patient had begun experiencing more convulsive seizures and status epilepticus.The physician elected to adjust the patient's medications.The patient's device was also found to be at end of service.The patient was referred to obtain a replacement.Surgery occurred on (b)(6) 2016 where the patient had their generator removed.A new generator was introduced and the patient's lead was contended.The high impedance persisted so the lead was replaced.No other relevant information has been received to date.The explanted product has not been received to date.

Manufacturer Narrative

Human error allowed the inappropriate term of contended to be used rather than connected.

Event Description

The patient's explanted lead has been received and is undergoing product analysis which has not been completed to date.Product analysis was completed on the generator used during surgery to test the lead and no anomalies were found.No additional relevant information has been received to date.

Manufacturer Narrative

(b)(4).

Event Description

Product analysis was completed on the patient's explanted generator.During analysis, the elective replacement indicator (eri) flag was set.An open can measurement of the battery voltage confirmed that the eri flag had been properly set; the device was operating at low battery voltage.Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to a ¿depleted¿ condition." product analysis was completed on the patient¿s lead.Lead continuity was tested and it was found that there was a discontinuity with the lead.Scanning electron microscopy images of the negative coil shows pitting and corrosion at the break location.The break appears to be stress induced in at least two strands of the coil.The lead insulation tubing was punctured by the negative electrode past the electrode bifurcation.Lead assembly has dried remnants of body fluid inside the inner silicone tubing at the connector region no obvious point of entrance was noted.No other anomalies were found that impacted the functionality of the device.The electrodes were not returned.No other relevant information has been received to date.

• Brand Name: 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: 6119116
• MDR Text Key: 60904312
• Report Number: 1644487-2016-02574
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/1998
• Device Model Number: 300-20
• Device Lot Number: 3487C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/1996
• 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: 36 YR