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 02/09/2024

Event Type  malfunction  

Event Description

On february 7, 2024, a patient called the impulse dynamics technical support hotline stating an a9 error code appeared on their charger when they attempted to charge their optimizer smart mini (osm) implantable pulse generator (ipg).The patient stated they were in a hospital but for an unrelated event.An id field representative coordinated a visit with the patient, and on february 9, the patient's device was interrogated and reset.The interrogation of 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 issue that has affected several other ipgs, and the patient was initially advised to charge their ipg only to 75 percent battery capacity to avoid the ipg entering down mode again.As rectification of this firmware bug is part of the new ipg firmware approved by fda on february 9, the patient's ipg was upgraded with the new firmware on march 4, 2024.The patient was advised that a modified charging protocol would no longer need to be followed, and 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 october 26, 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: 18841483
• MDR Text Key: 336970854
• Report Number: 3012563838-2024-00012
• 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: Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 03/05/2024

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 Expiration Date: 10/22/2023
• Device Model Number: CCM X11
• Device Catalogue Number: 10-B501-3-XX
• Device Lot Number: H4751
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2024
• 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