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

Model Number 102

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

Patient Problem Pain (1994)

Event Date 01/28/2019

Event Type  Injury  

Event Description

It was reported that the patient underwent prophylactic replacement.The patient alleged feeling like stimulations were more painful than before.It is not clear if the painful stimulation was a contributing factor to the patient's referral for replacement.No additional or relevant information has been received to date.The explanted device has not been received for analysis to date.

Event Description

The generator was received for product analysis.Product analysis was completed and approved.The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.The device performed according to functional specifications.No additional or relevant information has been received to date.

• Brand Name: PULSE GEN 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: 8399500
• MDR Text Key: 138105952
• Report Number: 1644487-2019-00431
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 04/08/2019

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: 01/05/2011
• Device Model Number: 102
• Device Lot Number: 201051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 03/07/2019
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 04/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2009
• 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: 63 YR