MAUDE Adverse Event Report: IMPULSE DYNAMICS USA INC CHARGER DEVICE; IMPLANTABLE PULSE GENERATOR

Patient Problems Heart Failure/Congestive Heart Failure (4446); Respiratory Insufficiency (4462)

Event Date 06/02/2023

Event Type  Injury  

Event Description

Reporter calling, stating her husband has a ccm (cardiac contractility modulation) optimizer smart mini implanted to help treat symptoms of heart failure.Reporter states that in the three months since the device was implanted, there have been eight instances of the charger overheating and shutting down whenever they attempt to charge the optimizer smart mini.Reporter states that when the charger overheats and shuts down, the optimizer smart mini cannot be fully charged and does not function very well and her husband has a difficult time breathing comfortably.Reporter states when the charger overheats, it produces an "a-9" error code.Reporter states eight separate times they have contacted technical support to troubleshoot this error code, requiring the charger to be reset in every instance.Reporter states she was told by the company representative that they are aware of "numerous problems" with the device and reporter states she was told "we are waiting for a fix from the fda (food and drug administration)." reporter states she feels the company is "giving us the runaround" and is being "dishonest" in their communication and attempts to help the reporter and her husband.Reporter is concerned and frustrated as her husband depends on this device to help manage his heart failure.Reference report: mw5145552.

• Brand Name: CHARGER DEVICE
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): IMPULSE DYNAMICS USA INC
• MDR Report Key: 17735363
• MDR Text Key: 323490966
• Report Number: MW5145553
• Device Sequence Number: 1
• Product Code: QFV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2023
• Patient Sequence Number: 1
• Treatment: OPTIMIZER SMART MINI.
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Male