MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problems High impedance (1291); Positioning Problem (3009)

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

Event Date 06/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a surgeon was seeing high impedance during a patient's initial implant surgery.High impedance was found during multiple system diagnostic tests.The surgeon then tried performing generator diagnostics and found the results were within normal limits.A replacement lead was used and the system diagnostics showed results within normal limits.The lead that was attempted to be used in surgery was returned in one piece and analysis was approved on 07/12/2016.The condition of the returned lead assembly was consistent with conditions that typically exist following an attempted implant procedure.Continuity checks of the returned lead assembly were performed with no discontinuities identified.Overall length and resistance measurements of the complete returned lead were determined to be in compliance with those defined in the manufacturing specifications.Five (5) half sets of screw marks were observed near the end of the connector pin, indicating that the lead pin had not been fully inserted into the generator block.The lead was inserted into a test generator and verified that there were no abnormalities with the connector boot.Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portion of the device which may have contributed to the reported high impedance.Incomplete insertion of the connector pin was the most likely cause for the observed high impedance condition during the implant of this lead.A review of the generator's device history record showed that the generator had passed all quality inspections prior to release for distribution.

Manufacturer Narrative

Describe event or problem, corrected data: the initial report inadvertently did not include the intraoperative impedance values.Relevant tests/laboratory data, including dates, corrected data: the initial report inadvertently did not include the intraoperative impedance values.

Event Description

A list of intraoperative impedance values from surgery on (b)(6) 2016 was provided for generator and system diagnostic tests.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• 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: 5793686
• MDR Text Key: 50409590
• Report Number: 1644487-2016-01577
• 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
• Type of Report: Initial,Followup
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2017
• Device Model Number: 105
• Device Lot Number: 203359
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2015
• 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: 13 YR