MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

Model Number 303-20

Device Problems Fluid/Blood Leak (1250); High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/03/2016

Event Type  malfunction  

Event Description

It was reported that a vns patient was referred for full revision as the last device interrogation resulted in high lead impedance.Clinic notes were received form a visit dated (b)(6) 2016 which provided that the patient's generator was interrogated and showed high impedance of greater than 10,000 ohms.The physician reduced the settings from 3.0 ma to 2.5 ma and pulse width increased from 250 to 500 and did not disable the device.Battery life was reported to be at 50%.Additional relevant information has not been received to-date.No known surgery has occurred to-date.

Event Description

Full revision surgery occurred on (b)(6) 2017.The explanted devices have not been received by the manufacturer to-date.

Manufacturer Narrative

Date received by manufacturer, corrected data: the date received by manufacturer was inadvertently provided as 02/15/2017, when it was intended to be 03/09/2017 for follow-up report #2 as this was a correction report only.

Manufacturer Narrative

Date returned to manufacturer, corrected data: the date the device was returned was inadvertently not provided in follow-up report #1.Device evaluated by manufacturer, corrected data: the field for device evaluation was inadvertently not marked in follow-up report #1.

Event Description

The explanted devices were received by the manufacturer.Analysis is underway, but has not been completed to-date.

Manufacturer Narrative

(b)(4).

Event Description

Analysis was completed for the returned generator.Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.An electrical evaluation showed that the generator performed according to functional specifications.The battery measured 2.989 volts and did not show an end-of-service condition.The downloaded data revealed that 59.694% of the battery had been consumed.There were no performance or any other type of adverse conditions found with the generator.Analysis was completed on the returned lead portion.A portion of the lead assembly including the electrodes was not returned for analysis and a complete evaluation could not be performed on the entire lead product.The connector pin tri-filar coil appeared to be broken approximately 249mm from the end of the connector boot.Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture with fatigue appearance and mechanical damage, pitting on one of the broken coil strands and evidence of a stress induced fracture due to rotational forces on two of the broken coil strands.Pitting and residual material were observed on the coil surface.The abraded openings found on the bilumen tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the bilumen tubing.With the exception of the observed discontinuity, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified.

• Brand Name: LEAD MODEL 303
• 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: 6068590
• MDR Text Key: 59032282
• Report Number: 1644487-2016-02527
• 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,Followup,Followup
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2015
• Device Model Number: 303-20
• Device Lot Number: 201887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2011
• 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: 25 YR