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 09/05/2023

Event Type  malfunction  

Event Description

During a follow-up visit on (b)(6) 2023, an impulse dynamics (id) field representative was notified by the hospital of a patient with an implanted optimizer smart mini device whose implantable pulse generator (ipg) had entered "ccm down mode".Field staff were dispatched and interrogated the patient's ipg, which yielded the error message: "telemet error: down_ tempera ture_integrity 3" error.The ipg was reset and reprogrammed, but on (b)(6) 2023, the patient contacted the id field representative to report an a09 error code appearing on their charger.The device was again reset and reprogrammed by id field staff, but the error code appeared again on (b)(6) 2023.Interrogation of the ipg in both instances yielded a "telemet error: down_charge_current_too_high" error message.The ipg was again reset and returned to normal function.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 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.The patient did not follow this advisement, though it is unclear if this was intentional or unintentional, and their ipg entered down mode again on (b)(6) 2023.At this time, the patient refused all requests to have their device interrogated and insisted on having the ipg removed.After consulting with the implanting physician on (b)(6) 2023, the patient's ipg was removed/explanted on september 5, 2023 with no issues or complications.The ipg exhibited no physical or fitment issues and was shipped to impulse dynamics usa, inc.For further evaluation.

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 100; marlton NJ 08053
• Manufacturer Contact: robert fasciano ; 401 route 73 n; bldg 50, ste 100; marlton, NJ 08053 ; 6174359098
• MDR Report Key: 18178109
• MDR Text Key: 328629551
• Report Number: 3012563838-2023-00019
• 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: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2023
• Device Model Number: CCM X11
• Device Catalogue Number: 10-B501-3-XX
• Device Lot Number: H4767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2021
• 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
• Treatment: MEDTRONIC DR DEFIBRILLATOR.
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Male