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

Model Number 103

Device Problem No Display/Image (1183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2018

Event Type  malfunction  

Event Description

It was reported that the patient's battery indicated 18-25% life remaining during an interrogation.It was reported that approximately 3 months later the patient's battery life indicator showed 50-75% remaining.A review of the device history records for the generator was performed and showed that no unresolved non-conformances were found and that the device met all functional specifications prior to distribution.The internal data of the generator from the two interrogation dates mentioned was reviewed.The percent battery remaining, based on the battery voltage when the generator showed 18-25% battery life remaining indicated that there was approximately 24% battery remaining.The percent battery remaining, based on the battery voltage, from 3 months later indicated approximately 60% battery life remaining.No further relevant information has been received to date.

Event Description

Additional internal data of the generator was reviewed.The percent battery remaining aligned with the battery voltage and battery status.There were no sudden drops in voltage detected and no anomalies with the internal data.No further 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
• 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: 8483157
• MDR Text Key: 140919712
• Report Number: 1644487-2019-00654
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• 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: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/26/2017
• Device Model Number: 103
• Device Lot Number: 300329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 04/11/2019
• Supplement Dates FDA Received: 05/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2015
• 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 Age: 68 YR