MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL UNKNOWN

Device Problems Fracture (1260); High impedance (1291)

Patient Problems Emotional Changes (1831); Sleep Dysfunction (2517); No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2019

Event Type  malfunction  

Event Description

X-rays were received by the representative with the report that there was higher/inconsistent lead impedance detected on the patient's generator.Per the x-ray images, the generator placement appeared to be in the upper left chest.The connector pin appeared to have been inserted completely per the images.The strain relief could not be assessed due to the quality of the images.One tie down appeared to be present; but based on the quality of the image provided it was unable to assess whether the tie down was the sole tie down and whether it was placed per labeling.Due to the quality and angle of the image an assessment could not be made regarding whether the lead was behind the generator or if the leads were intact at the connector pin.No gross lead fracture or sharp angles were observed in the visible portion of the lead; however, the entire lead body could not be accurately assessed.Based on the images provided, no obvious source of the high impedance was observed; however, the presence of micro-fractures cannot be ruled out.No known relevant surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

It was reported that high impedance was detected at a routine follow-up appointment.It was reported that the patient was referred to discuss options with their surgeon.There was reportedly no known trauma or manipulation that could have contributed to the high impedance.It was reported that the high impedance resolved when the patient was positioned differently.It was reported that the patient's generator output currents were disabled as it was difficult to assess possible discomfort and the patient experienced episodes of intermittent disturbed behavior and poor sleep.Multiple attempts have been made to obtain additional information; however, no further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

• Brand Name: LEAD MODEL UNKNOWN
• Type of Device: LEAD
• 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: 8613484
• MDR Text Key: 145233277
• Report Number: 1644487-2019-00930
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2019

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 05/15/2019
• Supplement Dates Manufacturer Received: 05/21/2019
• Supplement Dates FDA Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 28 YR