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

Model Number 1000

Device Problems Failure to Interrogate (1332); Mechanical Problem (1384)

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

Event Date 08/20/2018

Event Type  malfunction  

Event Description

It was reported that during surgery, a sentiva could not be interrogated in the package.The error message observed was reportedly "could not interrogate device, no device found." one programming system was used and no attempts to eliminate electromagnetic interference was made.Review of the generator's data found that the generator was not responding to communication attempts.The manufacturer's device history records of the generator were reviewed, and the device performed to all specifications prior to release.No non-conformances were noted.The generator was received but product analysis has not been completed on the generator to date.No further relevant information has been received to date.

Event Description

Furth investigation determined that the event was related to a microcontroller manufacturer-related defect that resulted in a lockup of the microcontroller, leading to loss of generator function and communication until a device reset was performed.This could be exacerbated by cold operating temperatures or a high frequency of transitions from low power mode to active mode (device ¿wakeups¿), among other factors.

Event Description

Product analysis (pa) was completed on the returned generator.The reported failure to communicate was duplicated in the pa lab.Probing on the module revealed that crystal oscillator was not operating.The generator was reset and normal programming was observed.Review of the data stored in the generator revealed that the date and time for the final electrical test event was incorrect.A review of the internal data of the generator revealed that the failure occurred the same day the generator was delivered.The generator operated properly after it was reset.Follow-up investigation was performed to the sales representative in the area where this event was observed to determine whether the medical facility had screening protocols in place that may have contributed to the crystal failures; however, no such procedures were identified.Additionally, the facility did not store the vns product in an abnormal environment 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7879305
• MDR Text Key: 120394394
• Report Number: 1644487-2018-01624
• 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,Followup,Followup
• Report Date: 04/01/2019

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: 05/15/2020
• Device Model Number: 1000
• Device Lot Number: 204516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 09/14/2018
• Supplement Dates Manufacturer Received: 10/24/2018; 04/01/2019; 04/01/2019
• Supplement Dates FDA Received: 11/19/2018; 04/01/2019; 04/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2018
• 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