MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/18/2019

Event Type  malfunction  

Event Description

It was reported that a generator could not be implanted during a generator replacement surgery since the setscrew felt loose and would not tighten.It was stated that lead pin was removed and reinserted before attempting to tighten the setscrew again.The silicone cover reportedly came off and the screw was seen to be loose in the socket area.Another generator was implanted with no issues.It was reported that no excessive force was used during the surgery and that the plug fell out while trying to tighten the screw.The surgeon ensured to turn the screwdriver the correct direction (clockwise) when tightening the screw.A review of device history records for the generator was performed and shows that no unresolved non-conformances were found.The device met all specifications for release prior to distribution.The suspect generator has not been received to date.No additional or relevant information has been received to date.

Event Description

The generator was received by the manufacturer and an analysis was performed on the returned generator.The header septum cavity meets specification requirements.No damage was observed on the septum cavity.The septum and setscrew were not returned.A torque wrench was able to tighten and release a test resistor with a bench setscrew.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.Based upon the analysis results that the generator is operating within specification, that there was no issue tightening and releasing a bench resistor with a bench setscrew, and that the device met all specification prior to release, the root cause of the detachment of the septum plug and inability to torque the setscrew appears to be associated with user error.No additional or relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000
• 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: 8371550
• MDR Text Key: 137243943
• Report Number: 1644487-2019-00365
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/09/2019

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: Health Professional
• Device Expiration Date: 09/13/2020
• Device Model Number: 1000
• Device Lot Number: 204658
• 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: 02/01/2019
• Initial Date FDA Received: 02/26/2019
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 04/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2018
• 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: 24 YR