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

Model Number 1000

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Chest Pain (1776)

Event Date 05/10/2018

Event Type  Injury  

Event Description

It was reported that a patient was implanted in (b)(6) 2018 and his device was not turned on until recently due to scheduling issues.The patient was programmed to 0.25ma.The patient returned today complaining of burning at the generator site.The patient was sent for x-rays, and the device was disabled.Ap and lateral x-rays of the neck and chest were available that displayed complete view of the neck and chest.Based on the images provided, the feedthrough wires appeared intact at the connector pins, and the generator was placed in the upper left chest, as expected.However, based on the angle of the image, the connector pin does not appear to be fully inserted past the connector block.The lead was observed in the patient¿s neck and was routed toward the patient¿s left chest.A strain relief bend and loop are present and placed per labeling.Two tie downs are present.Both tie downs appear to be securing the strain relief loop per labeling but no tie down appears to be securing the bend.No obvious fractures or sharp angles were found in the images.Note that a portion of the lead was routed behind the generator so it could not be assessed.Based on the images provided, the patient¿s painful stimulation may be related to incomplete lead pin insertion.Note that the presence of micro-fractures could not be ruled out.Patient was referred to surgery for consult.No additional or relevant information has been received to date.

Event Description

At the patient's follow-up visit, high impedance stated to have been seen on the device and the patient was scheduled for a lead pin reinsertion.Pre-op testing found high impedance.The surgeon attempted pin reinsertion and impedance was still high, so they tested the generator with a test resistor and diagnostics indicated ok at 4100 ohms.At this point, the surgeon was not comfortable with the high reading, so he decided to open a new generator.The new generator was connected to the lead and diagnostics indicated 5444 ohms.A test resistor was not used to test this new generator at this time.The surgeon decided it was probably the lead that was defective, and he performed a revision of the old lead.The old lead was extracted and a new lead was implanted.The new lead was connected to the new generator and impedance indicated 9000 ohms.A second test was run indicating 9000 ohms.The or representative stated that at this point in the surgery, he rebooted and double checked his programmer and reran the diagnostic test.Impedance still indicated 9000 ohms.This was likely incomplete pin insertion as well.The original generator was still present in the operating room, so the surgeon decided to insert the new lead into the original generator.Impedance showed 1878 ohms.The new generator was then tested with a test resistor, and impedance was 4074 ohms.The surgeon made the decision to implant the original generator with the new lead as long as diagnostics were consistently ok.Three more diagnostics were run and showed impedances of 6189 ohms, 1716 ohms, and finally 1689 ohms.The first high reading was due to pin insertion which was corrected.With this, the surgeon felt comfortable using the original generator with the new lead, and the patient was closed up.The explanted devices have not been received for analysis to date.

Event Description

The lead was received into analysis on 09/11/2018.Analysis in underway but has not been completed to date.

Manufacturer Narrative

(b)(4).

Event Description

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.The second generator was implanted and explanted the same day due to high impedance, and returned to the company for analysis.Product analysis for the unused generator was completed.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.Electrical test results showed that the pulse generator performed according to functional specifications.Examination of the setscrew showed that the top of the hex head was damaged rounded out.These conditions could cause the inability to tighten the lead in the connector block, the material would not allow the torque wrench tip to insert properly into the hex head to tighten setscrew.Device history records were reviewed for the generator all specifications were passed prior to distribution into the field.No additional or relevant information has been received to date.

Event Description

Product analysis for the lead was completed and approved.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator.The additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified.Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities in the returned portions of the device.

• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7567346
• MDR Text Key: 110028578
• Report Number: 1644487-2018-00930
• 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: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/14/2019
• Device Model Number: 1000
• Device Lot Number: 204236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2017
• 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: 54 YR