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

Model Number CCM X11

Device Problem Failure to Charge (1085)

Patient Problem Failure of Implant (1924)

Event Date 02/08/2024

Event Type  Injury  

Event Description

On february 8, 2024, impulse dynamics received confirmation of a device explantation that occurred outside of the united states.The optimizer smart mini (osm) implantable pulse generator (ipg) had previously entered down mode due to battery depletion, and was unable to be interrogated or charged by an impulse dynamics field representative.Attempts to re-pair the device with a new charger were equally unsuccessful.Without being able to charge, interrogate, or pair the device, the decision was made to replace it, and the patient underwent replacement surgery on february 8.Due to the inability to interrogate the device, the error code associated with the down mode cannot be determined.No complications were reported and the newly implanted device has been functioning as intended.The leads were left in place, disconnected from the explanted device, and then connected to the newly implanted ipg.The explanted ipg was sent to impulse dynamics in a sealed biohazard bag inside of an unsealed exaktpak box.Impulse dynamics usa in marlton, new jersey received the device on february 21.Upon initial evaluation, the device did not respond to interrogation attempts, did not appear in any search loops, and was unable to send or receive any kind of signal.X-rays were taken of the device but showed no abnormalities.The device was sent out to be decontaminated' by an approved decontamination facility.Once this is complete, the device will be sent back to impulse dynamics usa to be further evaluated and the investigation will continue.

Event Description

This is a follow-up to a previously filed mdr.On may 15, 2024, members of the impulse dynamics product development team completed an evaluation of this explanted device after it had been decontaminated by an approved decontamination facility.The issue was determined to be a reinitialization error by the zarlink communication chip.Once the zarlink chip was manually reset, communication could once again be established with the ipg and the ipg could exit down mode.However, the root cause of the initial malfunction of the zarlink chip remains under investigation.

• 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: 18840344
• MDR Text Key: 336959914
• Report Number: 3012563838-2024-00011
• 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
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CCM X11
• Device Catalogue Number: 10-B501-3-XX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Other