MAUDE Adverse Event Report: LIVANOVA USA, INC. BIPOL LEAD MODEL 300

Model Number 300-20

Device Problem High impedance (1291)

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

Event Date 03/14/2019

Event Type  malfunction  

Event Description

Patient presented with high impedance.There was no reported trauma in the area of the device.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Further information was received from clinic notes.Clinic notes indicate that the device has a lead fracture.High impedance was noted suggesting the lead fracture.Patient was referred for lead revision.No known surgical intervention has occurred to date.

Event Description

Patient underwent full revision (replacement of the lead and generator).The explanted products have not been received by product analysis to date.

• Brand Name: BIPOL LEAD MODEL 300
• 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: 8516598
• MDR Text Key: 142364256
• Report Number: 1644487-2019-00729
• 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,Followup
• Report Date: 06/10/2019

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: 07/31/2002
• Device Model Number: 300-20
• Device Lot Number: 255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/25/2019
• Initial Date FDA Received: 04/15/2019
• Supplement Dates Manufacturer Received: 04/25/2019; 05/17/2019
• Supplement Dates FDA Received: 05/17/2019; 06/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2000
• 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: 28 YR