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

Model Number 106

Device Problems Premature End-of-Life Indicator (1480); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 07/02/2015

Event Type  malfunction  

Event Description

It was noted that the manufacturer's battery life calculation did was not close with the patient's generator battery status, so the internal data of the generator was reviewed to determine whether the generator was depleting normally.Review of the data identified premature battery depletion.The generator's voltage indicated that the generator had 8.07% of its battery life remaining; however, based on stimulation provided by the generator, the minimum % battery life remaining should be minimum ~17%.Per a review of the manufacturer's device history records, the generator passed final quality and functional specifications prior to release.The generator was laser-routed.From a previous internal investigation, it is known that some laser-routed devices may be susceptible to premature battery depletion.The observed premature battery life indicator was most likely caused by conductive debris from the laser-routing process, which resulted in current leakage paths and premature depletion.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Event Description

The patient's generator was replaced prophylactically.The explanted generator was discarded.No further relevant information has been received to date.

Manufacturer Narrative

B4.Date of this report, corrected data: the initial mdr inadvertently reported that the date of report was 01/21/2020 instead of 01/21/2021.B5.Describe event or problem, corrected data: the initial mdr inadvertently did not clarify that a livanova employee identified the potential for premature end of life.

Event Description

A company employee noted the difference between the manufacturer' battery life calculation and the generator's battery status.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11211156
• MDR Text Key: 228173205
• Report Number: 1644487-2021-00083
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: 08/18/2021

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: 06/16/2017
• Device Model Number: 106
• Device Lot Number: 4397
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/29/2020
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 04/12/2021; 08/19/2021
• Supplement Dates FDA Received: 05/07/2021; 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 12 YR