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

Model Number 304-20

Device Problems Fracture (1260); High impedance (1291)

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

Event Date 07/19/2015

Event Type  malfunction  

Event Description

An international distributor reported that a device was exhibiting high lead impedance via system diagnostics.The physician elected to turn the device off.X-rays were provided to the manufacturer for review.X-ray evaluation found that the generator placement appeared normal in the left upper chest area and the feedthru wires appear to be intact.A gross lead fracture was observed possibly near the clavicle with severe twisting of the lead coil(s)below the clavicle and above the pulse generator.The lead pin appeared to be inserted just past the connector block but due to the angle of the pulse generator and the image quality it could not be conclusively assessed.The physician stated that the patient's convulsions may be responsible for the lead fracture.The patient's generator and lead were explanted and replaced.The explanted generator and lead have been returned to the manufacturer and are currently undergoing product analysis.

Event Description

Product analysis was completed on the returned lead.During the visual analysis several areas of the outer silicone tubing appeared to be compressed and twisted.The positive and negative quadfilar coils were observed to be broken in several places.The coil breaks showed signs of wear, pitting, mechanical damage, and stress induced fracture (including rotational forces).It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.Abrasions were noted on both the inner and outer silicone tubing.The compressed and twisted conditions observed in the quadfilar coil break areas of the lead tubing suggest the two issues may be related to one another.With the exception of the observed discontinuities and twisted/compressed lead tubing, the condition of the returned lead portions 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.Note that since a portion of the (+) white and (-) green electrode inner silicone tubes and quadfilar coils including the anchor tether and (+) white electrode were not returned, an evaluation and resulting commentary cannot be made on that portion of the lead.

Manufacturer Narrative

Describe event or problem, corrected data: information was inadvertently not indicated in the initial mfg.Report.

Event Description

Corrected data: it was reported that the pulse generator was replaced prophylactically and the battery had not reached its ifi point.New information: it was reported that when reviewing x-rays before the surgical revision to those taken after the initial implant, the direction of the generator was different.From this the physician concluded that external factors (the patient's convulsions) led to both the generator migration and the lead fracture.It was reported that the explanted lead was strongly pulled and twisted by the generator due to the patient's convulsions.It was reported that the physician used non-absorbable sutures during the initial implant procedure.Product analysis of the returned pulse generator showed that there were no performance or any other type of adverse conditions found with the generator.Review of the ram/flash data downloaded from the generator shows an indication of increased impedance from 7738 ohms to 11550 ohms on (b)(6) 2015.During product testing various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications with an ifi = no condition.The returned lead remains under product analysis.

• 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: 5022388
• MDR Text Key: 24683903
• Report Number: 1644487-2015-05553
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2017
• Device Model Number: 304-20
• Device Lot Number: 3769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2013
• 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: 42 YR