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

Model Number 300-20

Device Problems Premature Discharge of Battery (1057); Corroded (1131); Fracture (1260); High impedance (1291); Communication or Transmission Problem (2896)

Patient Problem Seizures (2063)

Event Date 06/02/2016

Event Type  malfunction  

Event Description

A call was received from the patient's mother indicating that the patient was experiencing an increase in seizures.While visiting the patient's physician it was noted that "there was an issue and that it (the patient's generator) was not functioning properly and that the result would be that the battery would be drained quickly." the mother also inquired about finding a surgeon that was performing vns surgeries in their area.The high impedance was identified on (b)(6) 2016, and there was low output current as well.It was unknown if the patient experienced any trauma or manipulation.X-rays were not performed.No surgical intervention has occurred to date.

Event Description

The patient had full revision surgery on (b)(6) 2016 due to the high impedance.The lead pin was re-inserted into the existing generator, but the high impedance did not resolve.It was observed that the lead was broken.Both the generator and lead were discarded, so no analysis could be performed.

Manufacturer Narrative

Follow-up report #1 inadvertently reported that the devices were discarded, but further information was received indicating that they were not discarded.Follow-up report #1 inadvertently reported the incorrect conclusion (b)(4) as the suspect device was not discarded.

Event Description

Clarification was received that the generator and lead were not discarded after explant.The generator and lead were received, but analysis has not been approved to date.

Manufacturer Narrative

(b)(4).

Event Description

Analysis of the lead was approved.Note that most of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product.During the visual analysis of the lead, what appeared to be rust-like deposits and pitting were observed on the unmarked connector pin surface.Scanning electron microscopy was performed and identified evidence of rust-like deposits and pitting on the surface of the unmarked connector pin.A definite cause for the pitting could not be determined based on the lead portion returned.The set screw marks found on the lead connector pins provided 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.No other obvious anomalies were noted except for the rust-like deposits and pitting observed on the unmarked connector pin surface.Analysis on the generator was approved.The data was downloaded and reviewed from the generator.The 22.687% of the battery had been consumed.Review of the data downloaded from the generator shows an indication of increased impedance, but the date that the high impedance was first present could not be identified.The device was interrogated and system diagnostic tests were performed resulting in ifi = no.Lead impedances and current delivered were normal for all diagnostic tests performed.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

• 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: 5927365
• MDR Text Key: 54532161
• Report Number: 1644487-2016-01993
• 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,consum
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2000
• Device Model Number: 300-20
• Device Lot Number: 11887C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/1998
• 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 Age: 32 YR