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 03/19/2024

Event Type  Injury  

Event Description

On march 19, 2024, impulse dynamics staff was informed by a representative working for a foreign distributor that a revision surgery had occurred for an optimizer smart mini (osm) implantable pulse generator (ipg).The device had previously been reported as experiencing issues with charging when done by the patient at home; an a9 error code had appeared on the charger screen.Two previous attempts were made by distributor reps to interrogate the device, but both were unsuccessful.Multiple troubleshooting attempts with the assistance of the impulse dynamics technical operations team were initiated but to no avail.The revision surgery occurred without incident, and the patient has been receiving ccm therapy as normal since the revision.The explanted device was sent and is intended to soon be received by impulse dynamics germany gmbh in frankfurt.A preliminary evaluation of the device will be conducted before the device is further processed and sent to an approved decontamination facility.

• 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: 19137837
• MDR Text Key: 340560584
• Report Number: 3012563838-2024-00018
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2024

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: Lay User/Patient
• Device Model Number: CCM X11
• Device Catalogue Number: 10-B501-3-XX
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2024
• 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 Outcome(s): Other
• Patient Sex: Male