MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problems Fracture (1260); High impedance (1291); Battery Problem: High Impedance (2947)

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

Event Date 09/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

High lead impedance was reported on a vns patient system.The high impedance was discovered a few months after the patient had a generator replacement due to battery depletion.A surgery was performed.After the generator was replaced, the lead impedance was within normal limits.The explanted generator will be returned to the manufacturer for analysis but has not been received to date.Review of manufacturing records confirmed all tests passed for the concerned generator prior to distribution.

Event Description

Further follow up indicated that no lead has been replaced.The explanted generator was received by the manufacturer on 11/21/2016.Analysis is underway but it has not been completed to date.

Event Description

The analysis on the generator was completed on (b)(6) 2016 and the reported high impedance on the generator was not duplicated.The review of the data downloaded from the pulse generator shows an indication of increased impedance; and the time of change detection was (b)(6) 2016 (explant date).Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.In the product analysis, the device output signal was monitored for more than 24 hours, while the pulse 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.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery, 2.932 volts as measured during completion of the final electrical test, shows an intensified follow-up indicator =no condition.The data in the memory locations revealed that 8.159% of the battery had been consumed.The pulse generator performed as intended and no anomalies were observed during the testing.Based on the available information, lead break is suspected in this case.The review of the manufacturing records confirmed all tests passed for the concerned lead prior to the distribution.

Event Description

Follow up indicated that the patient was recently by the neurologist in the consultation.They performed a system diagnostic test on the patient¿s device and everything seems normal, the impedance value was around 2300 ohms, even when the test performed while the patient was moving his head and shoulder.

• Brand Name: PULSE GEN MODEL 103
• 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: 6075168
• MDR Text Key: 59357583
• Report Number: 1644487-2016-02544
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/26/2017
• Device Model Number: 103
• Device Lot Number: 300327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/10/2016
• Initial Date FDA Received: 11/03/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/15/2016; 01/12/2017; 02/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2015
• 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: 29 YR