MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

Device Problem High impedance (1291)

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

Event Date 12/27/2018

Event Type  malfunction  

Manufacturer Narrative

Voluntary medical device correction (remedial action) was initiated by the manufacturer on 11/16/2018 via physician notification letter.

Event Description

It was reported that a patient's device was showing impedance of 5500 ohms.The patient was a new patient implant and impedance from the case was noted to be 2908 ohms.It was suggested that the physician continue to monitor the patient's impedance values and perform x-rays.Device history records were reviewed for the implanted devices.Both devices were sterilized and passed all quality inspections prior to distribution.It was reported that the patient was in clinic again and was now presenting with impedance of 5146 ohms.It was stated that the patient has not have any recent trauma.At another office visit, the mother noted that she would feel tingling from swiping the magnet over the patient's device.It was clarified that the report of the mother feeling tingling from swiping the magnet was not replicated at the appointment and that the patient also did not know what the mother was referring to.The mother had stated that this only occurred once "recently", but it was not specified when.The physician did not have an assessment about the event and it was noted that the patient's settings were at normal mode and magnet mode output currents of 0.5ma and 0.75ma.It is known that the vns device does not stimulate externally.Internal investigation identified that a change in the timing of the impedance test may result in higher impedances for model 1000 generator compared to those reported by model 103-106 generator.As indicated in the physician's manual, high lead impedance (>/= 5300 ohms), in the absence of other device-related complications, is not an indication of a lead or generator malfunction.No relevant surgical intervention has occurred to date.No additional relevant information was received to date.

Event Description

X-rays were received for review.The x-ray report indicated that the vns was in place "without evident lead discontinuity".No abnormalities were noted.Per the x-rays, the generator placement appeared to be normal in the left axillary chest area.Complete pin insertion was visualized as the lead pin appeared to extend past the second connector block.The feed-through wires appeared normal.The lead was observed in the neck and chest.Note that a portion of lead was routed behind the generator and so could not be assessed.The strain relief bend was present per labeling, however no strain relief loop was observed.Due to the image quality, only one tie down could be visualized.The observed tie down was not placed per labeling as it was securing the strain relief bend.In the portions of the lead visible, no gross lead fractures or other anomalies were observed.Based on the images provided, no obvious cause for the high impedance was identified.Note that the presence of problems in obscured portions of the lead and microfractures cannot be ruled out.No relevant surgical intervention has occurred to date.No additional relevant information was received to date.

• Brand Name: PULSE GEN MODEL 1000
• 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: 8265894
• MDR Text Key: 133693451
• Report Number: 1644487-2019-00118
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2020
• Device Model Number: 1000
• Device Lot Number: 204549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2018
• 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: 33 YR