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

Model Number 1000

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Patient Involvement (2645)

Event Date 06/13/2019

Event Type  malfunction  

Event Description

It was reported that a connection could not be established with a packaged m1000 generator in the hospital's inventory.It was reported that two different programming systems were attempted to be used but were unable to communicate with the generator.The facility marked the device as "non-readable" and opted to retrieve a replacement generator.A review of device history records revealed that the generator passed all functional specifications and quality tests prior to distribution.The generator was received by the manufacturer for product analysis; however, product analysis has not been completed to date.No further relevant information has been received to date.

Event Description

The generator was returned in its sterile packaging and product analysis was completed.The failure to program reported was not duplicated in product analysis and the generator was removed from its sterile packaging.The generator was interrogated with the programming system in product analysis with the wand at multiple orientations and the generator communicated successfully with each attempt.Systems diagnostics were performed and results indicated that communication was ok, lead impedance and current delivered were all within normal limits.The generator reed switch was within specification; however, was near the high-end of the specification, which caused the generator to require a larger magnetic field strength for the final electrical test.Product analysis indicated that the reed switch sensitivity would not effect the ability of the generator to communicate with the programming system in the field.No further 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: 8768444
• MDR Text Key: 150293590
• Report Number: 1644487-2019-01318
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/03/2021
• Device Model Number: 1000
• Device Lot Number: 204895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2019
• 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