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

Model Number CCM X11

Device Problem Computer Software Problem (1112)

Patient Problem Failure of Implant (1924)

Event Date 03/26/2024

Event Type  malfunction  

Event Description

On (b)(6) 2024, a patient in germany called the impulse dynamics patient hotline to report an a9 error displaying on their charger while attempting to charge their smart mini implantable pulse generator (ipg).An impulse dynamics field representative saw the patient the next day ((b)(6)) and interrogated and reset the device.Upon interrogation, the ipg yielded a "telemet error: down_charge_current_too_high" error.Analysis of the ipg log files confirmed this is the same, known high charge current (hcc) issue that has affected several other ipgs.The patient was advised to charge their ipg only to 75 percent battery capacity to avoid the ipg entering down mode again.The rectification of this firmware bug is currently under review for eu approval.The patient has been receiving ccm therapy as normal since the reset of the initial down mode.

Manufacturer Narrative

This report is being filed in response to the outcome of discussions between impulse dynamics and fda on (b)(6) 2023.

• Brand Name: OPTIMIZER SMART MINI
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): IMPULSE DYNAMICS USA, INC.; 401 route 73 n; bldg 50, ste 110; marlton NJ 08053
• Manufacturer Contact: robert fasciano ; 401 route 73 n; bldg 50, ste 110; marlton, NJ 08053 ; 6174359098
• MDR Report Key: 19059697
• MDR Text Key: 340474464
• Report Number: 3012563838-2024-00016
• Device Sequence Number: 1
• Product Code: QFV
• UDI-Device Identifier: 00810003380098
• UDI-Public: 00810003380098
• Combination Product (y/n): N
• PMA/PMN Number: P180036/S007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 04/08/2024

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 Operator: Lay User/Patient
• Device Model Number: CCM X11
• Device Catalogue Number: 10-B501-3-XX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male