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 12/24/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, a patient called the impulse dynamics (id) technical support hotline to report that, according to the device charger, their implantable pulse generator (ipg) had gone into down mode for the third time in three weeks.When the patient's ipg was interrogated by an id field representative, the device produced a "down_temperature_integrity" error, the same error that the device had produced in the previous two instances.The patient's ipg was reset on december 29 and the ability of the device to deliver ccm therapy was restored.However, the patient informed the id field representative the next day (december 30) that the ipg had again gone into down mode and showed an error code on the charger.The patient's ipg was again interrogated on (b)(6) 2024, which yielded another "down_ tempera ture_integrity'' error.After interrogation, the ipg was again reset and ccm therapy was resumed.On january 8, the patient again called the id technical support hotline to report their ipg had yet again entered down mode and showed an error code on the charger.On january 11, the patient's ipg was interrogated again, which produced another "down_temperature_integrity" error, and reset.Since this latest event, the patient's ipg has delivered ccm therapy without interruption.

• 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: 18557976
• MDR Text Key: 333477872
• Report Number: 3012563838-2024-00004
• 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
• Type of Report: Initial
• Report Date: 01/22/2024

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
• Device Lot Number: H4984
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male