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

Model Number 105

Device Problem Energy Output To Patient Tissue Incorrect (1209)

Patient Problems Dysphagia/ Odynophagia (1815); Neck Pain (2433); No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2017

Event Type  malfunction  

Event Description

A physician reported that he had interrogated a patient's generator with his handheld, which was plugged into the wall outlet, and observed that the output current had inadvertently been changed from 2.25ma to 0ma.The physician's partner unplugged the handheld from the wall and interrogated the generator again, and the generator output current had spontaneously changed back to 2.25ma without a programming event.Diagnostics were performed for the patient's device and returned results within the normal limits.A final interrogation was performed to confirm the correct device settings.The physician denied the possibility that a partial programming event had occurred at the previous clinic visit and caused the device disablement due to the fact that the patient reported feeling stimulation since the previous visit.No additional relevant information has been received to date.

Manufacturer Narrative

Adverse event or product problem, corrected data: initial report inadvertently did not include patient adverse events that occurred as a result of the reported problem outcomes attributed to adverse event, corrected data: initial report inadvertently did not include results of patient adverse events that occurred as a result of the reported problem describe event or problem, corrected data: initial report inadvertently did not include patient adverse events that occurred as a result of the reported problem event problem cds, patient code, corrected data: initial report inadvertently did not include patient adverse events that occurred as a result of the reported problem.

Event Description

The patient experienced painful stimulation as a result of the reported spontaneous change to the 2.25 ma output current.The patient's vns output current was decreased to 1 ma in response.The patient later reported that she also experienced choking and gagging during the clinic visit as a result of perceived overstimulation of her throat.No additional relevant information has been received to date.

Manufacturer Narrative

Describe event or problem, corrected data: follow-up report #01 inadvertently did not include information regarding the patient's planned surgery.

Event Description

The patient was referred for generator replacement surgery.The patient believed that her generator was defective because of the adverse events she experienced related to the increased output current.The patient later underwent generator replacement surgery.The explanted generator was returned to the manufacturer for analysis, but analysis has not been approved to date.No additional relevant information has been received to date.

Event Description

Analysis was approved for the returned generator.The generator was interrogated and system diagnostics were performed.The generator was interrogated, and system diagnostics were performed and returned results within the expected limits.The generator output was monitored for 24 hours in a simulated body environment.The generator did not vary in its output signal and demonstrated the expected level of output current.The generator was opened.A visual examination of the internal circuitry revealed no visual anomalies.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.Additional product analysis results are discussed in mfr.Report #1644487-2018-00708.No additional relevant information has been received to date.

Event Description

Further analysis of the generator was completed and is documented in mfr.Report # 1644487-2018-00708.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7118975
• MDR Text Key: 94997383
• Report Number: 1644487-2017-05003
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750054
• UDI-Public: 05425025750054
• 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,Followup,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2017
• Device Model Number: 105
• Device Lot Number: 4219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/16/2017
• Initial Date FDA Received: 12/14/2017
• Supplement Dates Manufacturer Received: 01/08/2018; 01/30/2018; 04/05/2018; 01/22/2019
• Supplement Dates FDA Received: 01/31/2018; 02/22/2018; 05/01/2018; 02/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2015
• 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 Outcome(s): Other
• Patient Age: 53 YR