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

Model Number 302-20

Device Problems High impedance (1291); Material Twisted/Bent (2981); Naturally Worn (2988)

Patient Problems Hemorrhage/Bleeding (1888); Tinnitus (2103); Twitching (2172); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/19/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient had high lead impedance and was referred for lead revision surgery the patient then reported now hearing a loud ringing noise, having a lower voice register, and muscle spasms causing her head to move to the side.She reported that during the appointment there were errors on the screen (indicative of high impedance), and she was referred for revision.The patient reported having had increased seizures in the week leading up to the lead revision surgery.The patient underwent lead revision surgery.During surgery, the lead was observed to be bent in a right angle, and there was scar tissue that was pulling on the jugular vein.It was noted that the lead body was twisted and kinked, and only one tie down was used on the lead.The surgeon replaced the lead and did not replace the generator.The surgery facility is known to discard all explants.No additional relevant information has been received to date.

Manufacturer Narrative

F10 medical device code, corrected data: initial report inadvertently did not include code a040507 "naturally worn" to describe the mechanical problem (damaged/kinked coil) f10 health effect - clinical code: code e2402 used as appropriate code "bleeding" not available.

Event Description

It was noted that the patient experienced bleeding due to manipulation of the vagus nerve/jugular vein during the lead revision procedure.No additional relevant information has been received to date.

Manufacturer Narrative

F10 health effect ¿ clinical code, corrected data: supplemental report #01 inadvertently did not include code ¿e0506 ¿ hemorrhage/bleeding¿.F10 health effect ¿ medical device code, corrected data: supplemental report #01 should have included code ¿a040609 ¿ material twisted/bent¿ instead of code ¿a040507 ¿ naturally worn.¿.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11495843
• MDR Text Key: 248034147
• Report Number: 1644487-2021-00357
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/17/2011
• Device Model Number: 302-20
• Device Lot Number: 200788
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR