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

Model Number 300-20

Device Problem High impedance (1291)

Patient Problem No Patient Involvement (2645)

Event Date 10/07/2019

Event Type  malfunction  

Event Description

The patient's physician has reported a high impedance reading on the vns therapy system.The physician performed chest x-rays for this patient which showed "left sided vagal nerve stimulator, lead appears grossly intact, lead is looped at the level of the t2 and t3 vertebral bodies." it was additionally noted that the patient has not experienced adverse events at this time.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Incoming communication from the representative indicated the physician did not troubleshoot the high impedance as the patient did not present with any symptoms.No further relevant information has been received to date.

Event Description

Further follow up with the sales representative confirmed that the patient's generator was interrogated with the m3000 v1.5 programming software, which is known to cause false high impedance error messages.No other relevant information has been received to date.

Event Description

Patient is being referred for a battery replacement due to his device being at 0%.No known surgical intervention has occurred to date.

Event Description

Patient underwent generator replacement.

Manufacturer Narrative

B5: describe event or problem; corrected information; supplemental mdr #3 inadvertently omitted information known prior to submission.

• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 9265753
• MDR Text Key: 164839355
• Report Number: 1644487-2019-02124
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2002
• Device Model Number: 300-20
• Device Lot Number: 33396C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2000
• 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: 55 YR
• Patient Sex: Male