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 11/28/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being filed in response to the outcome of discussions between impulse dynamics and fda on october 26, 2023.

Event Description

On july 5, 2023, a patient called their regional impulse dynamics field representative because their optimizer smart mini device entered ccm down mode due to an a9 error code, according to the display on their ipg charger.The patient's device was reset and reprogrammed, but the patient reported the same error message appearing again on november 1, 2023.The ipg was interrogated by a technician and 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 advised to charge their ipg only to 75 percent battery capacity (3 of 4 bars displayed on the charger) to avoid the ipg entering down mode again.The patient agreed and has continued to receive ccm therapy as normal since this advisement.The permanent fix for this issue will be implemented as part of a future firmware update that is currently pending finalization before being submitted to fda for review and approval.

Event Description

This is a supplemental report to the previously filed (b)(4).The patient agreed to adhere to the previous 75-percent charging advisement, but on (b)(6)2023, it was reported that the patient's device had entered down mode again with an a9 error code displaying on the charger.The device was interrogated and yielded the same "telemet error: down_charge_current_too_high" error that had previously been documented.The patient was reminded of the previous 75-percent charging advisement to mitigate recurrence.The permanent fix for this issue will be implemented as part of a future firmware update that is currently pending finalization before being submitted to fda for review and approval.

• 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 100; marlton NJ 08053
• Manufacturer Contact: robert fasciano ; 401 route 73 n; bldg 50, ste 100; marlton, NJ 08053 ; 6174359098
• MDR Report Key: 18115612
• MDR Text Key: 328633064
• Report Number: 3012563838-2023-00014
• 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,Followup
• Report Date: 11/30/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CCM X11
• Device Catalogue Number: 10-B501-3-XX
• Device Lot Number: H4836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/07/2022
• 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