MAUDE Adverse Event Report: LIVANOVA USA, INC. GENERATOR MODEL 102

Model Number 102

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

Patient Problems Pain (1994); No Code Available (3191)

Event Date 10/24/2019

Event Type  Injury  

Event Description

Patient referred for device explant due to the device migrating towards the patient's left breast as well as the device causing pain.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.The physician¿s assessment of the migration was reported to be unknown.The intervention was reported to be for patient comfort.The cause of the pain was noted to be migration.

• Brand Name: GENERATOR MODEL 102
• 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: 9446580
• MDR Text Key: 170119648
• Report Number: 1644487-2019-02382
• Device Sequence Number: 1
• Product Code: MUZ
• 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: 02/26/2020

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: 07/21/2007
• Device Model Number: 102
• Device Lot Number: 013894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: 02/11/2020
• Supplement Dates FDA Received: 02/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2005
• 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: 60 YR