OPTIMIZER Smart MiniRecalls & reported problems

Summary

The FDA's MAUDE database contains 125 adverse event reports that list this exact device (DI 00810003380098), received between Oct 6, 2023 and Sep 27, 2026 — classified as 2 deaths, 75 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (26 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jan 5, 2024Open, Classified

   OPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging error. This may cause patients to experience heart failure symptoms similar to before implantation of the device.

   Z-1173-2024 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 125 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2026Signal Artifact/Noise

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910420 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  An Impulse Dynamics field representative was informed on (b)(6) 2026 that a patient implanted with an OSM IPG had their device explanted during a lead extraction procedure. In the process of removing both pacing leads from the left ventricle, the physician decided to explant the entire implanted system, which included the OSM IPG. The IPG was discarded by the hospital after explant and is therefore not available for evaluation. There is no evidence at this time to indicate device malfunction prior to explant.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50592173 ↗
• InjuryAug 14, 2026Failure to Calibrate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258207 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50258204 ↗
• InjuryAug 14, 2026Misassembly by Users

  During an initial implantation procedure of an OSM IPG, the physician needed to reposition a lead after connecting IPG to both leads. The set screws were backed out too far and fell out of the threads. Impulse Dynamics field representatives attempted to guide the physician through the process of re-seating the screw. Physician attempted to remove the seal plug to re-seat the set screw but in doing so damaged the seal plug. A backup device was provided and was successfully connected to the leads after lead repositioning was complete. The original IPG was decontaminated at an approved decontamination facility before being returned to Impulse Dynamics USA for evaluation. Damage was observed on the seal plug of the V1 distal setscrew which was consistent with the reported complaint description. After removing the damaged seal plug the setscrew was able to tighten down successfully. Visual inspection of the setscrew revealed no stripping or other damage. All 6 setscrews were then tightened to full depth and backed out without any issues. Testing of the electronic controls passed all checks. The root cause of this issue was determined to be user error during the implant procedure. During

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258203 ↗
• InjuryAug 14, 2026Failure to Seal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258201 ↗
• InjuryAug 14, 2026Misassembly by Users

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258199 ↗
• InjuryAug 14, 2026Misassembly by Users

  During an initial implantation procedure of an OSM IPG, the set screw came out when the doctor was moving leads for the second and third time. The Impulse Dynamics field representative observed the set screw went sideways and the doctor couldn't fix it. A backup IPG was used to complete the procedure without incident. The original IPG was scrapped by the hospital and was therefore unavailable for evaluation. Backing out the IPG set screws too far is a known user complication, though this particular issue could not be further investigated as the device was not returned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258195 ↗
• InjuryAug 14, 2026Misassembly by Users

  During the initial implantation procedure of an OSM IPG, the physician removed the lead from header to reposition the lead. When attempting the reconnect the lead into the header, the distal set screw would not go in. The physician was unable to reseat the set screw after multiple attempts. A backup IPG was ultimately implanted without incident. The original IPG was decontaminated at an approved decontamination facility before being returned to Impulse Dynamics USA for evaluation. X-rays taken upon its return showed no misalignment of the setscrews. The set screw hardware itself was functioning correctly and was not faulty. All setscrews were successfully driven to full depth and backed out without any issues when using a hex wrench. Testing of the electronic controls passed all checks. After a more detailed examination of the x-rays, it was observed that the V2 distal screw block was slightly misaligned. Additional testing by the Product Development team confirmed that, despite the slight misalignment, it remained within specifications. Since the setscrews were confirmed to be functional and not misaligned, the root cause of the difficulty in reseating the distal set screw is like

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258190 ↗
• InjuryAug 14, 2026Misassembly by Users

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258186 ↗
• InjuryAug 14, 2026Misassembly by Users

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258183 ↗
• InjuryAug 14, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258179 ↗
• InjuryAug 14, 2026Misassembly by Users

  It was reported that during an OUS OSM IPG implant procedure there was a problem with the stable signal. The lead located in the V2 connector was unscrewed and disconnected from IPG. After the test was done successfully it was impossible to screw it again because the proximal screw had broken. The distal screw was screwed in without any trouble. The lead was stable on the connector, but the measured impedance was over 2000 ohms. The physician ultimately decided to swap the IPG with the backup. All settings were copied and the backup IPG was implanted without incident.The original IPG was decontaminated at an approved decontamination facility before being returned to Impulse Dynamics USA for evaluation. When attempting to connect the IPG to the AETS, it was noted that the hex of the V2 tip set screw was stripped and would not engage with torque wrench when attempting to tighten the set screw. The device passed electronic controls testing after replacing the stripped set screw. The root cause of this issue was determined to be user error. The set screw was excessively unscrewed in addition to being connected and disconnected from the leads several times. This overuse of the hexagonal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258176 ↗
• InjuryAug 14, 2026Misassembly by Users

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258169 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pocket Erosion

  MAUDE report 50258165 ↗
• InjuryAug 14, 2026Misassembly by Users

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258162 ↗
• InjuryAug 14, 2026Delayed Charge Time

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 50258154 ↗
• InjuryAug 14, 2026Failure to Charge

  A patient reported an A9 error code appeared on their charger while trying to charge their implanted OSM IPG, but before an Impulse Dynamics field representative could see them, the patient developed an infection and the IPG was explanted by the physician. The hospital confirmed the IPG was scrapped but that the infection was unrelated to the device. A DHR review was conducted and no anomalies were found. There is no evidence at this time to suggest the device caused or contributed to the infection. The patient later passed away due to unrelated medical reasons.

  Patient problems: Unspecified Infection

  MAUDE report 50258151 ↗
• InjuryAug 14, 2026Failure to Charge

  A patient implanted with an OSM IPG presented for a pocket revision and lead reposition due to Twiddlers. Lead repositioning was accomplished and the pocket was revised. Post-implant communication with the device was unachievable and the physician felt it was most likely due to her having not charged the device for a few weeks. The physician advised the patient to charge the IPG overnight, but the next day, the hospital NP advised the Impulse Dynamics field representative that the patient was unable to charge as planned. The rep began trying to charge the device by repositioning the charger antennae and interrogate the device with the INTELIO. The device was unable to be charged and interrogated, and was replaced the next day.The explanted IPG was decontaminated at an approved decontamination facility and was returned to Impulse Dynamics USA for evaluation. It was not possible to interrogate the device. The can was opened, and the operation of the circuit was observed. The power rail was correct, indicating intact fuse and sufficient battery voltage. Both microcontrollers were observed to be executing. The communication lines between the telemetry microcontroller and the radio modu

  Patient problems: Twiddlers Syndrome

  MAUDE report 50258147 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pocket Erosion

  MAUDE report 50258139 ↗
• InjuryAug 14, 2026Misassembly by Users

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258136 ↗
• InjuryAug 14, 2026Device Sensing Problem

  Patient problems: Electric Shock

  MAUDE report 50258133 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Wound Dehiscence

  MAUDE report 50258130 ↗
• InjuryAug 14, 2026High impedance; Misassembly by Users

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258119 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  A patient implanted with an OSM IPG was hospitalized on (b)(6) 2026 for infection. The cardiologist on call suspected the OSM IPG was infected and subsequently removed the device three days later. Blood cultures came back positive, so per hospital policy, the device was discarded immediately following explant. Therefore, evaluation of the device itself will not be possible. A DHR review was conducted and no anomalies were found, including any in the sterilization records of the IPG. It remains unknown at this time what was the initial source or cause of infection, but there is no evidence at this time to suggest it was the implanted OSM IPG.

  Patient problems: Unspecified Infection

  MAUDE report 50149733 ↗