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

Model Number 102

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 04/04/2018

Event Type  malfunction  

Event Description

It was reported that when the generator was removed from the packaging for a new patient implant, it was noted that the septum plug was half out of the generator.When the septum plug was touched by the surgeon, it fell out, enabling sight directly into the header.The setscrew stayed in.As a result, the generator was not implanted.There was nothing unusual about the packaging observed prior to the removal of the generator.The manufacturer's device history records of the suspect generator was reviewed.The generator passed final quality and functional specifications prior to release.The suspect product has not been received to date.No further relevant information has been received to date.

Event Description

The suspect product was received for analysis, but product analysis has not been completed to date.

Manufacturer Narrative

(b)(4).

Event Description

Product analysis was completed on the returned generator.The generator's setscrew was not returned.Dimensional analysis of the septum plug and septum plug hole identified that the specification requirements were met.A bench set screw was able to be installed and tightened normally.No visual anomalies with the connector block setscrew threads were identified.By reviewing the device history records, it was determined that the setscrew and septum plug placement was verified by two manufacturing operators.An x-ray confirmed that the setscrew was present at time of manufacture.The generator performed according to functional specifications with no anomalies identified.Note that because the set screw was not received, an evaluation and resulting commentary cannot be performed.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: 7470467
• MDR Text Key: 106852634
• Report Number: 1644487-2018-00685
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750016
• UDI-Public: 05425025750016
• Combination Product (y/n): N
• 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
• Report Date: 06/25/2018

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: 08/02/2019
• Device Model Number: 102
• Device Lot Number: 204270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/04/2018
• Initial Date FDA Received: 04/27/2018
• Supplement Dates Manufacturer Received: 04/30/2018; 06/07/2018
• Supplement Dates FDA Received: 05/25/2018; 06/25/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/10/2017
• 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