MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem High impedance (1291)

Patient Problem Seizures (2063)

Event Date 07/19/2017

Event Type  malfunction  

Event Description

Patient underwent prophylactic generator replacement.During the replacement, high impedance was observed on both the old and new generator.A microfracture is suspected since or specialist verified proper lead insertion and the high impedance was still occurring on both generators.System diagnostics were verified to be run multiple times and eventually the high impedance was resolved.The first couple tests showed impedance >10,000 ohms initially, and then the tests showed the following impedances: 8560, 7173, 5933, 2413, 2186, 2093, and 1640 ohms.As the final two tests showed normal impedance, the surgeon decided to close up the patient's incision without replacing the lead.The device was left programmed off.The explanted generator was received and analysis is underway but has not been completed.Per clinic notes received for patient's replacement referral, the parents reported that they swipe the magnet with each seizure cluster up to five times, but feel it has not been helpful.No additional relevant information has been received.

Event Description

Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified in the product analysis lab.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.Magnet activations performed during output monitoring (at a distance of one-inch, spacer block, from the generator), demonstrate the appropriate magnet output for the programmed settings.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, with the exception of the expected low battery.The electrical performance of the generator, as measured in the lab, was used to conclude that no anomalies exist and the near-end-of-service (neos) condition is an expected event.No additional performance or any other type of adverse conditions found with the pulse generator.Additional programming data was received.Based on the decoder data, the high impedance observed on the day of replacement is believed to be incomplete pin insertion.Per the decoder, the explanted generator's last known 25% change in impedance prior to troubleshooting done during the surgery was from 6/7/2017 (993 ohms to 2780 ohms).This indicates that there was no high impedance present before the day of surgery.On the day of surgery, the explanted generator showed high impedance on only instance and a subsequent system diagnostic test following the high impedance observation showed normal impedance.Therefore it is likely that the one instance of high impedance is due to incomplete pin insertion, which resolved after proper pin insertion for the next system diagnostic test.

Manufacturer Narrative

Describe event or problem, corrected data: supplemental mdr #1 inadvertently left out some information that was intended to be reported.

Event Description

For the newly implanted generator at the time of surgery, there were several system diagnostic tests that showed high impedance initially.However the last few (5) system diagnostics showed normal impedance with values 2413, 2186, 2093, 1960, and 1640 ohms.As impedance slowly decreased and returned to normal impedance for the new generator, there is no generator issue suspected.It is likely that the lead pin was not inserted the first few tries of the diagnostics that resulted in high impedance.After lead pin manipulation and troubleshooting during the surgery, the impedance likely returned to normal limits when proper connection between the lead pin and the generator was established.

• Brand Name: PULSE GEN MODEL 105
• 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: 6790663
• MDR Text Key: 82706926
• Report Number: 1644487-2017-04294
• 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,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2019
• Device Model Number: 105
• Device Lot Number: 204017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2017
• 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: 18 YR