MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 303

Model Number 303-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Numbness (2415); Neck Pain (2433); Subcutaneous Nodule (4548)

Event Date 09/29/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient reported that her device has been disabled for years as she did not need it because her seizures are not epileptic.She noted that she has hard lumps around the lead as well as numbness, pain, and a pulling sensation through her neck to her ear.She is trying to have the device explanted since she no longer needs it.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Event Description

The patient's device was explanted and was discarded per hospital policy.No further relevant information has been received to date.

• Brand Name: LEAD MODEL 303
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 12419026
• MDR Text Key: 269790327
• Report Number: 1644487-2021-01248
• 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
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/22/2014
• Device Model Number: 303-20
• Device Lot Number: 200310
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR