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

Model Number 102

Device Problem Protective Measures Problem (3015)

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

Event Date 04/29/2008

Event Type  malfunction  

Event Description

A generator underwent product analysis after being explanted due to battery depletion.Product analysis verified low battery condition with normal current consumption rates.In addition, an automated electrical test was performed which indicated that the generator did not meet the specifications for the backup capacitor-to-can measurements.It was confirmed via other tests that the positive feed-thru capacitor was electrically open.This was visually confirmed during analysis.After the open positive back-up capacitor was fixed, the generator performed as intended with no anomalies identified.The out of specification capacitor provides electromagnetic protection if the need arises and will only affect device functionality in the presence of an mri electronic field.The cause of this problem is believed to be related to the manipulation of the feed-thru wires during generator production.No further 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7799000
• MDR Text Key: 117697063
• Report Number: 1644487-2018-01447
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/24/2018

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: 03/31/2010
• Device Model Number: 102
• Device Lot Number: 2064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/25/2018
• Initial Date FDA Received: 08/20/2018
• Supplement Dates Manufacturer Received: 09/12/2018
• Supplement Dates FDA Received: 09/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2008
• 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: 54 YR