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

Model Number 302-20

Device Problem Fracture (1260)

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

Event Date 07/09/2019

Event Type  malfunction  

Event Description

Patient presented with high lead impedance.The patient was referred for x-rays and full revision (replacement of the lead and generator).Neck lateral and chest ap x-rays were received for the patient.The generator was located in the patient¿s upper left chest.The connector pin cannot be seen coming through the second connector block due to the angle of the image.The filter feed thru were confirmed to be intact.The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest.There was a portion of the lead that was routed behind the generator, and the lead wires appeared intact at the connector pins.No sharp angles were identified in the visible portion of the lead.In the visible portions of the lead, no discontinuities were observed.A portion of the lead near the generator was unable to be assessed for discontinuity due to the angle and contrast of the image.The cause of the patient¿s high impedance could not be determined based on the images provided.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Patient underwent full revision surgery (replacement of the lead and generator).The explanted products have not been received by product analysis 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8841121
• MDR Text Key: 152635834
• Report Number: 1644487-2019-01472
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/06/2008
• Device Model Number: 302-20
• Device Lot Number: 1330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2005
• 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: 18 YR