MAUDE Adverse Event Report: IMPULSE DYNAMICS USA INC. OPTIMIZER; IMPLANTABLE PULSE GENERATOR

Model Number OPTIMIZER COMPETITOR CRHF PRIMARY

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

Event Type  malfunction  

Event Description

It was reported that the product was incorrectly registered to the patient.The serial number was corrected.The product remains in use.No patient complications have been reported as a result of this event.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: OPTIMIZER
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): IMPULSE DYNAMICS USA INC.
• MDR Report Key: 18895341
• MDR Text Key: 337676505
• Report Number: MW5152721
• 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: Unknown
• Type of Report: Initial
• Report Date: 01/30/2024

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 Model Number: OPTIMIZER COMPETITOR CRHF PRIMARY
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2024
• Patient Sequence Number: 1