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

Model Number 106

Device Problem High impedance (1291)

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

Event Date 08/03/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

High impedance was found at a patient铠first vns dosing appointment after initial implant.The device was not turned on and the patient has not experienced any discomfort.X-rays of the implanted device were reviewed by the manufacturer.The connector pin did not appear fully inserted into the connector block.The lead wires appeared intact at the connector pin.

Manufacturer Narrative

Event description, corrected data: the report of the patient's consult for surgery was inadvertently not included on the initial report.

Event Description

The patient has had a surgical consult scheduled for revision of the lead pin.No known surgery has occurred to-date.

Event Description

Lead pin insertion revision surgery was performed (b)(6) 2015.The lead pin was removed and then re-inserted and the impedance issues were reported to be corrected.

• 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: 5039651
• MDR Text Key: 25151215
• Report Number: 1644487-2015-05627
• 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: Followup
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/02/2017
• Device Model Number: 106
• Device Lot Number: 4405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2015
• 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: 67 YR