MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem High impedance (1291)

Patient Problem No Code Available (3191)

Event Date 05/17/2017

Event Type  malfunction  

Event Description

It was reported that a vns patient was seen by their physician and high impedance was noted.The patient was referred for revision surgery.Clinic notes were received from a visit on 05/17/2017 indicating the patient is having less frequent episodes.Interrogation of the vns showed high lead impedance.Clinically, the patient is not feeling all firing and especially when he is using the magnet.

Event Description

The patient underwent surgery, and during pre-operative system diagnostics, high impedance was confirmed.X-rays displayed in the or indicated the lead pin may have not been fully inserted.The surgeon then examined the lead in the generator and stated he thought he could see the lead pin fully inserted.The lead pin was removed and no anomalies were noted.The generator socket also appeared clear.The lead pin was re-inserted fully and the set screw tightened to multiple clicks.Two system diagnostics, one out-of-pocket and one in-pocket indicated normal impedance.

• Brand Name: PULSE GEN MODEL 106
• 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: 6633170
• MDR Text Key: 77304984
• Report Number: 1644487-2017-03958
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/12/2019
• Device Model Number: 106
• Device Lot Number: 204004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2005
• 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 Outcome(s): Required Intervention
• Patient Age: 27 YR