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 01/29/2024

Event Type  malfunction  

Manufacturer Narrative

Warnings regarding electrosurgery including the use of electrocautery devices are present in current osm ifus.If proper, attentive care is not exercised during such a procedure, it risks permanent damage and/or failure of the device.

Event Description

On january 29, 2024, it was reported that the impulse dynamics technical support hotline received a call from a patient claiming their optimizer smart mini (osm) implantable pulse generator (ipg) could not be charged.The patient reported that their charger used to charge the ipg was unable to locate or communicate with the ipg.The patient reported the screen on the charger did not show a connection present among the middle bars.The charger would then beep, show an "x" on the screen, and tum off without ever successfully pairing with the ipg.Prior to this incident, the patient never experienced difficulty in having the charger connect and charge the ipg following the instructions in the osm patient's manual.The patient was seen by an impulse dynamics field representative on january 30, during which the rep confirmed the charging issue and unsuccessfully attempted multiple device interrogations and troubleshooting solutions.The logs from the patient's ipg were downloaded and showed the last successful communication between the charger and ipg was on january 24.It was then discovered that on (b)(6), the patient had been seen by a dermatologist for a spot removal on the skin near where the ipg was implanted.The procedure had been performed via cauterization, but impulse dynamics was never notified before the procedure took place.After multiple, unsuccessful troubleshooting attempts as well as an internal review of device records with manufacturing and product development engineers, the likely outcome of this situation will be an outright replacement of this ipg.Impulse dynamics is in the process of finalizing a recommendation before coordinating between the patient and implanting physician.An explant procedure has not yet been scheduled.Note: when a patient is implanted with an osm ipg, they receive a physical implant card with the details of their device.The card also has a statement on the front side advising "please keep this card with you at all times and show it to medical personnel who might treat you." this is so contact can be established between an hcp and impulse dynamics prior to a procedure taking place.

• 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: 18772599
• MDR Text Key: 336992930
• Report Number: 3012563838-2024-00009
• Device Sequence Number: 1
• Product Code: QFV
• 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: 02/23/2024

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: H5050
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2024
• 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