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

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problems Seizures (2063); Inadequate Pain Relief (2388)

Event Date 06/28/2013

Event Type  Injury  

Event Description

It was reported that the vns patient was experiencing painful stimulation in his neck.The patient¿s device settings were lowered but the patient subsequently experienced an increase in seizures.The patient¿s device settings were programmed back to previous settings and the patient¿s painful stimulation returned.X-rays dated (b)(6) 2013 were provided to the manufacturer for further review.The generator appears in the left chest in a normal placement.The filter feed-through wires appear to be intact.The lead connector pin appears fully inserted into the generator connector block.The electrodes appeared to be placed in normal arrangement.Part of the lead was behind the generator and could not be assessed.No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed.Based on the images provided, the cause of the reported event remains unknown.Follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2013.The replacement generator was tested with the existing lead and diagnostics showed lead impedance within normal limits (impedance value ¿ 1650 ohms).The patient continued to experience painful stimulation following surgery.The explanted generator has not been returned to date.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

Event Description

On (b)(6) 2014, it was reported that this patient¿s explanted generator was discarded at the time of explant.Attempts for additional information have been unsuccessful.

Manufacturer Narrative

Previously submitted mdr indicated this information was unknown.It is now known.This report is being submitted to correct this data.

• Brand Name: PULSE GEN MODEL 102
• 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: 4245608
• MDR Text Key: 5107126
• Report Number: 1644487-2014-03002
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/26/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2015
• Device Model Number: 102
• Device Lot Number: 202460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2013
• 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: 44 YR