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

Model Number CCM X11

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fungal Infection (2419)

Event Date 04/17/2024

Event Type  Death  

Event Description

On (b)(6) 2024, an impulse dynamics representative was informed of the explant of an optimizer smart mini (osm) implantable pulse generator (ipg) that had taken place the day prior, february 5.Since the initial implantation that occurred on (b)(6) 2024, the patient had developed a fungal infection, which prompted the decision made by the cardiothoracic surgeon to explant the patient's ipg.The explant was completed successfully without any complications, and the patient was transferred post-op to the icu to recover from the surgery as well as stave off the infection with iv antibiotics.A review of the device's sterility records revealed no abnormalities, and there is no indication that the ipg itself caused or contributed to the patient's infection in any way.Note that the initial osm ipg implantation procedure for this patient had to be rescheduled twice due to infusion port access issues and infection.The device is currently under quarantine at the hospital awaiting additional testing for infection type.Depending on the type and severity of the infection, the device will either be discarded (ex.If mrsa detected) or will be sent to the impulse dynamics site in marlton, new jersey for further evaluation.

Event Description

This is an amendment to a previously filed mdr.On (b)(6) 2024, an impulse dynamics field representative was informed by a representative from the hospital that this patient had expired.Due to this, the hospital is not willing to release the explanted osm ipg back to impulse dynamics usa for further evaluation.There is no evidence to indicate the device caused or contributed to the infection.

• 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: 18797486
• MDR Text Key: 336509266
• Report Number: 3012563838-2024-00010
• 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,Followup
• Report Date: 05/07/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: CCM X11
• Device Catalogue Number: 10-B501-3-XX
• Device Lot Number: H5070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/07/2024
• 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): Hospitalization; Death; Other
• Patient Sex: Male