MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Energy Output Problem (1431)

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

Event Date 09/18/2018

Event Type  malfunction  

Event Description

It was reported that a current not delivered error message was seen that stated that the programmed current was not being delivered at the specified level.It was reported that this occurred when the pulse width was programmed to 750usec and the output current was programmed to 3.5ma, and that the event resolved when the pulse width was programmed to 250 usec and the output current was programmed to 3.5ma.It was also reported that when the error message was received that the patient reported that they no longer felt the stimulation and that they no longer experienced voice alteration, which normally occurred during stimulation.Internal data of the generator was reviewed and the last output current delivered was 3.25ma even with the generator programmed to 3.5ma.Lead impedance was within normal values for the available internal data for the generator.After applying ohms law with the tolerance of the lead impedance measurement, it appears the device would be able to deliver the programmed normal output current with the given lead impedance including the 10% tolerance for the lead impedance.A review of the device history records for the generator shows that no unresolved non-conformances were found.The device met all specifications for release prior to distribution.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8405443
• MDR Text Key: 138358845
• Report Number: 1644487-2019-00463
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: Physician
• Type of Report: Initial
• Report Date: 03/08/2019

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: 11/01/2018
• Device Model Number: 106
• Device Lot Number: 5112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2016
• 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: 39 YR