MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL UNK; GENERATOR

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/27/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: device evaluation is not necessary as the hemorrhage is not related to the functionality or delivery of therapy of the device.

Event Description

It was reported that a clinical trial patient experienced a 2mm hemorrhage.The patient was to be implanted however due to the hemorrhage, they did not move forward with the implantation.It was stated that the hemorrhage occurred during surgery, and was due to the surgeon cutting through a particularly fibrous area which had caused a 2mm incision in the jugular vein.It was stated that this was sutured and rectified immediately and the implant was abandoned.It was reported the surgery did not move forward for the patient's safety.It was stated that the physician does alleged the hemorrhage due to the vns surgery as it is documented in the patient's electronic records that it had occurred while creating the incision for the implant.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL UNK
• Type of Device: GENERATOR
• 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: 8721968
• MDR Text Key: 148758660
• Report Number: 1644487-2019-01184
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/28/2019
• Was Device Evaluated by Manufacturer?: No
• 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