MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problems Fracture (1260); Low impedance (2285)

Patient Problem No Information (3190)

Event Date 03/23/2016

Event Type  malfunction  

Event Description

It was reported by the physician's office that a low impedance warning was observed during system diagnostics on (b)(6) 2016.It was noted the patient was not complaining about any painful or erratic stimulation.Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Corrected data.

Event Description

No surgical interventions has occurred to date.

Event Description

It was later reported the patient underwent a successful full revision.The pre-op interrogation of the patient's device showed low impedance.When explanting the m103 generator, the surgeon stated there was an obvious lead fracture near the generator, but he was not able to determine the cause of the fracture.The m103 generator and the old lead, up to the point of the anchor tether, were explanted and the electrodes were left in place.A new lead and generator were implanted with the new electrodes placed superior to the old electrodes.System diagnostics were checked for the newly implanted vns and noted to be within normal limits.The explanted product was sent to pathology per hospital protocol.The explanting facility does not return devices back to the manufacturer; therefore, the devices are not expected to be returned for analysis.

• Brand Name: PULSE GEN MODEL 103
• 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: 5590484
• MDR Text Key: 44011080
• Report Number: 1644487-2016-00840
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2011
• Device Model Number: 103
• Device Lot Number: 2590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2010
• 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: 34 YR