MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102R; GENERATOR

Model Number 102R

Device Problems Break (1069); Difficult to Remove (1528); Device Inoperable (1663)

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

Event Date 04/10/2015

Event Type  malfunction  

Event Description

It was reported that the patient's generator was replaced due to end of service on (b)(4() 2015.During the surgery, it was mentioned that the surgeon had difficulty removing the lead from the to be explanted generator.As a result, the header on the explanted generator broke during this explant process.It was confirmed that the header was not broken prior to the surgery.Diagnostics performed with the old generator and newly implanted generator were reported to be within normal limits.The explanted generator was returned to the manufacturer.Analysis is underway but has not been completed.

Manufacturer Narrative

(b)(4).

Event Description

Based on the location of the tool marks observed on the pulse generator case and header, the header detachment was determined to have most likely occurred during or after the explant process.Other than the header observation, there were no performance or any other type of adverse conditions found with the pulse generator.

• Brand Name: PULSE GEN MODEL 102R
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4752475
• MDR Text Key: 5826650
• Report Number: 1644487-2015-04634
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2012
• Device Model Number: 102R
• Device Lot Number: 201724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/08/2015
• Initial Date FDA Received: 05/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2011
• 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: 48 YR