MAUDE Adverse Event Report: IMPULSE DYNAMICS IMPLANTABLE PULSE GENERATOR

Model Number 10-8501-3-X

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Event Description

Caller stated patient was recently implanted with optimizer and is asking if that may be causing the unusual qrs morphology.While on the phone, another transmission was received and egm morphology looked normal.Discussed that based on morphology change from the 2 transmissions that optimizer was likely causing the difference in morphology (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: IMPLANTABLE PULSE GENERATOR
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): IMPULSE DYNAMICS
• MDR Report Key: 17489825
• MDR Text Key: 320710481
• Report Number: MW5122343
• Device Sequence Number: 1
• Product Code: QFV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2023

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?: No
• Device Model Number: 10-8501-3-X
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1