MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

Device Problem Battery Problem (2885)

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

Event Date 10/06/2017

Event Type  malfunction  

Event Description

It was reported that this patient's device was showing to have a battery status indicator of 25%, which the doctor did not expect, as the generator was only implanted a few months ago.Electrocautery was reported to have been used during the patient's previous replacement generator surgery.The device history record of the generator was reviewed, and it shows that no unresolved non-conformances were found.Data from the patient's device was reviewed and it confirms that the battery depleted more quickly than expected.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Patient device was reported to be at end of service.The patient¿s mother had not decided if the patient should have their device replaced as the patient had been seizure free.No surgical intervention is known to have occurred to date.

Event Description

It was reported that the patient's generator was replaced.Historically, the explanting facility does not return explanted products; therefore, return of the suspect product is not expected to date.No further relevant information has been received to date.

Event Description

It was reported that the patient's generator had reached intensified follow-up indicator yes battery status (ifi=yes).No further relevant information has been received to date.

Event Description

It was reported that this patient's device was interrogated and is no longer showing an end of service (eos) = yes warning, but the battery rebounded now showing an intensified follow-up indicator (ifi) = no battery status indicator.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 104
• 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: 6991698
• MDR Text Key: 90958609
• Report Number: 1644487-2017-04704
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750047
• UDI-Public: 05425025750047
• 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,Followup,Followup,Followup
• Report Date: 12/16/2019

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: 11/19/2018
• Device Model Number: 104
• Device Lot Number: 5157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/06/2017
• Initial Date FDA Received: 10/31/2017
• Supplement Dates Manufacturer Received: 02/16/2018; 12/21/2018; 09/04/2019; 12/06/2019
• Supplement Dates FDA Received: 03/09/2018; 01/15/2019; 09/24/2019; 12/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2017
• 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: 45 YR