MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problem No Information (3190)

Event Date 07/30/2020

Event Type  Injury  

Event Description

It was reported that the patient was hospitalized due to an unspecified adverse event.No additional relevant information has been received to date.

Manufacturer Narrative

B5.Describe event or problem - correction - generator replacement was inadvertently not included on supplemental #1.D7.Explant date - correction - explant date was inadvertently not included on supplemental #1.

Event Description

It was reported the patient had a generator replacement occur.The explanted device was discarded.No additional relevant information has been received to date.

Manufacturer Narrative

B2.Outcomes attributed to adverse event - correction - "required intervention to prevent permanent impairment/damage" and "other serious" options were not selected in the initial mdr.B5.Describe event - correction - information was not included in initial mdr.H6.Evaluation codes - method - correction - code 4117 was not coded in the initial mdr.

Event Description

It is unknown if the event is related to low battery or cardiac issue.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10535879
• MDR Text Key: 207012764
• Report Number: 1644487-2020-01211
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/06/2020

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: 02/13/2016
• Device Model Number: 103
• Device Lot Number: 3884
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/15/2020
• Supplement Dates Manufacturer Received: 10/09/2020; 10/13/2020
• Supplement Dates FDA Received: 10/09/2020; 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 66 YR