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 Bacterial Infection (1735)

Event Date 03/01/2024

Event Type  Injury  

Event Description

On march 1, 2024, an impulse dynamics field representative was informed that a patient's optimizer smart mini (osm) implantable pulse generator (ipg) device and its connected leads were explanted.The patient had developed an infection, thus leading to the decision by the implanting physician to explant the !pg and leads.The infection was suspected to be staphylococcus, but the results of the swab and culture testing performed by the hospital have not been made available to impulse dynamics at the lime of this report.The ipg was packaged and sent to impulse dynamics usa, inc.For evaluation and to confirm the ipg was fully functional at the lime of explant.After the ipg was decontaminated at an approved decontamination facility, it was returned to impulse dynamics usa for evaluation on march 18, 2024.The device passed all final electronic controls testing and no malfunctions were observed.Device logs indicated that no device failure had ever occurred.All set screws were operational when testing was performed.A review of device sterilization records was conducted and no anomalies were found.There is no evidence to indicate the ipg was not fully functional at the time of explant.

• 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: 19006479
• MDR Text Key: 338939877
• Report Number: 3012563838-2024-00014
• 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: 03/29/2024

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: H5085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2024
• 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
• Patient Sex: Male