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

Model Number 102

Device Problem Failure to Align (2522)

Patient Problems Itching Sensation (1943); Muscle Spasm(s) (1966); Undesired Nerve Stimulation (1980); Pain (1994); Seizures, Absence (2261); Therapeutic Response, Decreased (2271); Discomfort (2330); Neck Pain (2433)

Event Date 08/22/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient was experiencing pain in his neck and arms.Diagnostic results showed lead impedance within normal limits (dc dc ¿ 2).Follow-up revealed that the patient had recently experienced a drop seizure which may have affected the patient¿s device.Following the drop seizure, the patient began experiencing an increase in seizures.During stimulation on-times, the patient experienced epiglottis contractions, itching around the neck, spasms of the left arm and pain the left arm.The patient stated that he was able to feel the electrical pulse from his device travel through the lead.X-rays were taken and no lead breaks were found; however, the physician stated that the electrodes appeared misaligned on the patient¿s nerve and suspected a partial detachment or shift of the electrodes.X-rays 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.It was noted that the electrode alignment on the vagus nerve did not follow a straight line.Based on the images provided, the cause of the reported events cannot be determined.No known interventions have occurred to date.

Event Description

It was reported that the patient's surgery was cancelled because device diagnostics were within normal limits.The generator was programmed back on.

• 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: 4113291
• MDR Text Key: 4939430
• Report Number: 1644487-2014-02442
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2014
• Device Model Number: 102
• Device Lot Number: 202085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2012
• 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: 29 YR