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 01/08/2019

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 m1000 device was showing high impedance at the patient's second visit following implantation surgery.Device history records were reviewed and the device passed all quality tests prior to distribution.X-rays were received.Per the x-rays, the generator placement appeared to be normal in the left axillary chest area.Complete lead pin insertion could not be assessed due to the angle and quality of the images provided.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 loop was present per labeling, however no strain relief bend was observed.One tie down was used to secure the strain relief.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.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.Existing recommendations, as described in the physician¿s manual, should still be followed.Additional investigation is underway.

Manufacturer Narrative

(b)(4).

• 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: 8297819
• MDR Text Key: 134769296
• Report Number: 1644487-2019-00194
• 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,health
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/21/2020
• Device Model Number: 1000
• Device Lot Number: 204543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2018
• 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: 34 YR