MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

Model Number 302-20

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2022

Event Type  malfunction  

Event Description

It was reported that the patient had a chest x-ray, and the results showed abnormality involving the metallic mesh device along the anterior chest as seen involving the wires with new coiling superiorly suggest disruption of the wires.X-rays have not been reviewed by manufacturer to date.No other relevant information has been received to date.

Manufacturer Narrative

B5.Corrected information, initial report: inadvertently omitted report of patient feeling buzzing around the device and has been picking at her device.

Event Description

It was reported that the cause of the coiled lead is unknown.It was also noted that patient has been feeling buzzing around the device and has been picking at her device.The patient's mother feels that the patient is picking at generator site due to the wires out of place and possibly stimulating the wrong area.X-rays of the generator reviewed by the manufacturers.The x-rays were provided after report of abnormal lead coiling.The generator placement was determined to be abnormal in the medial chest.Based on the images provided, the feedthrough wires and the connector pin cannot be assessed due to poor image quality.The lead could not be completely visualized in the chest and neck due to image quality.The presence of strain relief and tie downs could not be assessed.The lead could not be properly assessed for fractures due to the image quality.There did appear to potentially be some coiled lead or mesh directly superior to the generator, but it cannot be confirmed exactly what this is due to the quality of the image.Based on the x-rays received, the cause of the coiled lead cannot be confirmed.Note that the presence of a micro-fracture and/or a lead discontinuity could not be ruled out in the portion of the lead that is not visible in the provided images.Report of picking at their device is found in mfr ref#1644487-2022-00586.No other relevant information has been received to date.

Event Description

It was later reported that patient was in pre-op for possible full revision.The reps asked surgeon for reason for revision he stated that it was due to patient experiencing buzzing sensation in chest that made patient pick at chest.At the time of buzzing sensation the output current was turned down to alleviate the buzzing until revision.During pre-op the interrogation the device was checked and everything looked fine.The magnet was swiped and the patient was asked where the buzzing sensation was felt.Patient reported that it was in the middle and right of her chest but they noted that vns is not placed in this portion of the body.The patient does have shunt placed in the area.A ct scan was also ordered and it was noted that there are no issues with vns therefore full revision was not done.Report of picking at their device is found in mfr ref#(b)(4) no known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 14488605
• MDR Text Key: 292508763
• Report Number: 1644487-2022-00598
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup,Followup
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/08/2010
• Device Model Number: 302-20
• Device Lot Number: 200419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/29/2022
• Initial Date FDA Received: 05/24/2022
• Supplement Dates Manufacturer Received: 05/25/2022; 06/21/2022
• Supplement Dates FDA Received: 06/17/2022; 07/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2007
• 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: 51 YR
• Patient Sex: Female