MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

Device Problem No Display/Image (1183)

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

Event Date 11/11/2020

Event Type  malfunction  

Event Description

It was reported that the patient's generator was interrogated a month ago and had 18-25% battery status, and then system diagnostics were performed and the battery showed 75-100%.The patient was then seen on (b)(6) 2020 and initial interrogation showed 18-25%.Diagnostics were then performed, and the battery was at 25-50%.The generator was reinterrogated w/ advanced interrogation, and again the battery showed 25-50%.Then two other tablets were used and showed 25-50% battery (the third tablet may have been a motion tablet, showing battery in the 25-50% range).The patient reported no issues with vns sensation or effectiveness of therapy, and no changes were made to the patient's settings.No additional information has been received to date.

Event Description

Tablet data download was received.It appears that the fluctuating battery status observed was due to the battery voltage being right at the 25% threshold, and therefore it is expected that the battery fluctuated between the 11-25% status indicator and the 25-50% status indicator.The remainder of the decoder was reviewed; no further anomalies were identified.Therefore, no device failure has occurred.

Manufacturer Narrative

H3.Device evaluated by mfr?, code 81: device evaluation is not necessary as the device failure was ruled out via data decoder review.

Event Description

The patient underwent prophylactic generator replacement.Product return and evaluation is not necessary as a device failure was previously ruled out via data decoder review.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 104
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11117288
• MDR Text Key: 225839664
• Report Number: 1644487-2021-00020
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750047
• UDI-Public: 05425025750047
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2021

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: 11/19/2018
• Device Model Number: 104
• Device Lot Number: 204039
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 03/09/2021; 04/16/2021
• Supplement Dates FDA Received: 04/01/2021; 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR