MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 101; GENERATOR

Model Number 101

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

Patient Problem Scarring (2061)

Event Date 08/19/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.

Event Description

Patient was referred for device explant due to the device disfiguring the patient resulting in the patient considering breast reconstruction surgery.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Further information was received from the physician that the cause of the device disfiguring the patient's chest was the presence of the device and device location at the patient's nipple line.It was noted by the physician that the referral for device explant was for patient comfort only.Patient underwent generator explant surgery.

• Brand Name: PULSE GEN MODEL 101
• 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: 9082373
• MDR Text Key: 158997619
• Report Number: 1644487-2019-01809
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

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: 12/11/2002
• Device Model Number: 101
• Device Lot Number: 3535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: 09/23/2019
• Supplement Dates FDA Received: 10/17/2019
• 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
• Patient Age: 47 YR