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

Model Number 104

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

Patient Problem Seizures (2063)

Event Date 11/02/2018

Event Type  Injury  

Event Description

Clinic notes received as part of the referral process for generator replacement noted that the patient's family has noticed an increased number of staring type spells (which have been consistent with the patient's partial complex seizures in the past), and that the patient felt that their vns might not be working as well.However, the device is noted to be at 18-25% battery status and lead impedance/output current are registering as ok.The physician confirmed that patient began experiencing increased seizures about 1-2 months prior to the office visit recorded in clinic notes, and that the patient's seizures are above pre-vns levels.The physician does not know the reason for increased seizures.No known surgical intervention has occurred and no other relevant information has been received to date.

Event Description

An implant card was received indicating that the generator was successfully explanted and a new generator was implanted.The implant card indicated that the reason for generator replacement was ¿prophylactic.¿ the explanted product is not available for return.The explant facility is known to discard explanted devices in the or.No other 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: 8292733
• MDR Text Key: 134594442
• Report Number: 1644487-2019-00154
• Device Sequence Number: 1
• Product Code: LYJ
• 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: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2011
• Device Model Number: 104
• Device Lot Number: 201081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2009
• 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: 78 YR