MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Energy Output To Patient Tissue Incorrect (1209)

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

Event Date 06/13/2018

Event Type  malfunction  

Event Description

It was reported that low output current was seen during implant of the generator.Data showed that no diagnostics were performed during the implant, so it could not be determined if the output current was delivered properly after the initial interrogation.Lead impedance was within normal limits, indicating that the lead was functioning properly.No further relevant information has been received to date.

Event Description

Data from the surgery was reviewed, and diagnostics were not performed on the generator.Therefore, the impedance value was only a stored value from manufacturing and not representative of the actual system impedance.Also, the output current delivered upon initial interrogation was 0ma, but the generator should have tried to deliver two on times of stimulation without success.The next interrogation had the same results of 0ma delivered.However, a final interrogation immediately after showed that the device delivered 2ma successfully.Without diagnostic results, it cannot be determined what caused the device to be unable to deliver the stimulation initially.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 7664919
• MDR Text Key: 113338830
• Report Number: 1644487-2018-01149
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2019
• Device Model Number: 106
• Device Lot Number: 204205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2017
• 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
• Patient Age: 33 YR