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

Model Number 302-30

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

Patient Problems Unspecified Infection (1930); Pain (1994); No Code Available (3191)

Event Date 04/23/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr? device evaluation is not necessary because the reported event have been determined as not related to vns therapy.(b)(4).

Event Description

It was reported that the patient¿s generator was protruding from her skin, and she was referred for surgery.Clinic notes received indicate that the wire was extruding through the skin and has been having pain.It was stated that there was an opening in the skin anterior to superior aspect of left axilla with lead protruding.Her husband stated that he believes a fall in the tub caused the extrusion.A fax was received from the physician.There was no obvious cause to the fall, and the protrusion started about a month prior.The surgery was for patient comfort and for possible infection.The patient¿s generator and lead were replaced.Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.No additional or relevant information has been received to date.

Event Description

Device history records were reviewed for the lead and the device was sterilized, and passed all specifications prior to distribution.

• 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: 8680066
• MDR Text Key: 147372295
• Report Number: 1644487-2019-01084
• 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: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/04/2004
• Device Model Number: 302-30
• Device Lot Number: 5986
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 06/07/2019
• Supplement Dates Manufacturer Received: 07/01/2019
• Supplement Dates FDA Received: 07/01/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/2002
• 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 Outcome(s): Required Intervention
• Patient Age: 70 YR