MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Seizures (2063)

Event Date 02/13/2018

Event Type  Injury  

Event Description

Clinic notes indicated that a patient was referred for generator replacement surgery after experiencing an increase in seizures.The patient's generator showed a 25% battery life remaining indicator.Follow-up with the nurse indicated that the patient's seizure increase was above her pre-vns levels.The cause of the seizures was unknown.The patient later reported experiencing breathing problems that she believed were related to depletion of the battery.Programming history was reviewed for the patient's generator.Diagnostics from a clinic visit 6 months prior to the reported increased seizures were within the normal limits.The patient underwent lead and generator replacement surgery.The company representative attending the surgery indicated that the generator battery was low, but she could not remember the battery status indicator she observed.The explanted devices have not been received by the manufacturer for analysis.No additional relevant information has been received to date.

Event Description

The explanted lead and generator were received by the manufacturer for analysis.Analysis was approved for the lead.Note a portion of the lead assembly including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product.The set screw marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present.No discontinuities were identified in the returned portion of the lead.There is no evidence to suggest an anomaly with the returned portion of the device.Analysis has not been approved for the generator to date.No additional relevant information has been received to date.

Event Description

Analysis was approved for the generator.When received, the final data was downloaded from the generator and reviewed.No anomalies were identified in the programming data.The generator output signal was monitored for 24-hours in a simulated body environment.The pulse generator showed no signs of variation in the output signal and demonstrated the expected level of output current.The pulse generator 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 104
• 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: 7345047
• MDR Text Key: 102623632
• Report Number: 1644487-2018-00419
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2012
• Device Model Number: 104
• Device Lot Number: 201567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2010
• 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: 49 YR