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

Model Number 303-20

Device Problems High impedance (1291); Difficult to Insert (1316)

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

Event Date 05/09/2017

Event Type  malfunction  

Event Description

It was reported that a lead could not be fully inserted into a generator, causing high impedance to occur during implant surgery.The surgeon tried removing and reinserting the lead multiple times, but the high impedance continued to occur.The lead could not be implanted due to the high impedance/insertion difficulties.The generator was tested with a test resistor and confirmed that it was accurately measuring impedance values.A different lead was implanted and post-op impedance values were all within normal limits.The lead that was not implanted has not been received by the manufacturer to date.

Event Description

The lead that was unable to be inserted was returned to the manufacturer for analysis.The visual analysis of the lead found the small o-ring appeared partially detached from the connector pin.Dimensional analysis was performed on the small o-ring, the large o-ring, the connector pin, and the connector boot and provided results all within normal limits.A half set of screw marks was identified on the lead pin confirming that the lead had not been fully inserted during implant.Continuity checks of the returned lead assembly verified that there were no discontinuities present.The remainder of the lead was within specifications and no other abnormal performance or other adverse conditions were identified.

Event Description

An internal investigation of pin insertion difficulties identified two possible cause of pin insertion difficulties.First, it was determined that if any lead's large o-ring boot diameter was closer to the assembly specification of 0.135 in max, it may cause insertion difficulty.Second, model 303 lead assembly document allows for di water to be used for lubrication of the pin for insertion, if required, although it is not prescribed in labeling.It is suspected that the costa rica manufacturing facility potentially used di water to lubricate the pin when excessive force was needed.This lead had both characteristics.The lead's large o-ring boot diameter was 0.134 in, which is close to the 0.135 inches specification max and therefore, may cause pin insertion difficulties.In addition, review of the device history records found that the lead was manufactured in costa rica and therefore may have been subject to di water lubrication.

• 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: 6604102
• MDR Text Key: 76392751
• Report Number: 1644487-2017-03902
• Device Sequence Number: 1
• Product Code: MUZ
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2019
• Device Model Number: 303-20
• Device Lot Number: 300347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2015
• 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: 40 YR