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

Model Number 102

Device Problems Failure to Deliver Energy (1211); Unexpected Therapeutic Results (1631)

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

Event Date 01/20/2015

Event Type  Injury  

Event Description

Clinic notes were received on (b)(6) 2015 for referral for battery replacement due to less efficacy being received from the device.Notes dated (b)(6) 2015 state that the patient has had few seizures and seizures are infrequent.The patient does not recall any seizures in the prior months.Follow-up showed that the patient is having an increase in seizure activity which is why less efficacy is thought to be received.The physician is concerned because her seizures have now included cluster seizures which is a new seizure type for the patient.It was noted that the patient doesn¿t feel stimulation as much and seizures have been aborted with magnet activation.There have been no change in medications leading to the increase in seizure activity.The patient can't tolerate vns settings beyond 1.75ma.The physician opted for prophylactic replacement and increased her oral medications until surgery.Surgery is likely but has not occurred to date.

Manufacturer Narrative

Review of the available programming and diagnostic history.

Event Description

The patient underwent replacement surgery on (b)(6) 2015 due to prophylactic neos=no.The explanted generator was received for analysis on 10/23/2015.Analysis is currently underway but has not been completed to date.

Event Description

Product analysis for the m102 generator was completed and approved on 11/17/2015.Based on the electrical test results, the device exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion to an eri condition.Therefore, the electrical performance of the generator, as measured in the product analysis lab, will be used to conclude that no anomalies exist and the eri condition is an expected event.The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.In addition, a comprehensive automated electrical evaluation showed that the pulse generator module performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.

• Brand Name: PULSE GEN MODEL 102
• 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: 4848231
• MDR Text Key: 5869590
• Report Number: 1644487-2015-04910
• 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,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2008
• Device Model Number: 102
• Device Lot Number: 015030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2006
• 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: 50 YR