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

Model Number 106

Device Problems Premature Discharge of Battery (1057); Premature Elective Replacement Indicator (1483); Battery Problem: High Impedance (2947)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2023

Event Type  malfunction  

Event Description

It was reported that the patients generator was recently interrogated and showed that it lost a significant amount of battery life even thought it has only been recently implanted.Internal generator data was received and reviewed.No system diagnostic information was available.It was found that the patient's device is prematurely depleting.It was noted that on 10/02/2023 only 7.543% of the battery was consumed meaning 92.457% of the battery should be remaining, not 21%.On 10/02/2023, the pbcr using history was 92.4567176 and the pbcr using vbat was 21.47288.Per the equation, vbat = 3.518778 + (92.4567176)*0.44567 = 44.72396 versus 21.47288 measured ¿pbcr using vbat¿ on the decoder.Since the measured vbat on the decoder is lower than what the formula gives, the device is below the 95% prediction interval and this is evidence that the battery is depleting faster than expected.No other relevant information has been received to date.

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanovas employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any defects¿ or malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Event Description

Additional information was received noting that upon an updated interrogation of the device, the battery has rebounded to 75-100%.Diagnostics were noted to be within normal limits.The battery rebound event was confirmed to be related to a known event cause by the impedance behaviors in the beginning of the battery's life.Internal investigation identified that in some cases, pulse generators reach the 25% battery indicator earlier than expected, and later rebound to 75-100% without any significant programming changes.This behavior was determined to be due to an increased duration of high battery impedance during generator battery beginning-of-life.There is no evidence of a device malfunction.

• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 18011166
• MDR Text Key: 326613106
• Report Number: 1644487-2023-01537
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 106
• Device Lot Number: 7498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2023
• 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: 24 YR
• Patient Sex: Male