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 Post Operative Wound Infection (2446)

Event Date 12/28/2023

Event Type  Injury  

Event Description

In (b)(6) 2023, a patient implanted with an optimizer smart mini implantable pulse generator (ipg) in october 2023 developed an infection from an iv access site.The infection then spread and traveled systematically until it also reached the site/pocket where the ipg was implanted.The ipg was explanted on (b)(6), 2023.Over the past three weeks, impulse dynamics representatives have attempted to coordinate receipt of the explanted ipg for analysis.However, the cardiac and pathology departments at the hospital confirmed the device had been discarded.While the device was not returned for analysis, available information from the hospital and impulse dynamics field representative shows the ipg was not the source of 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 100; marlton NJ 08053
• Manufacturer Contact: robert fasciano ; 401 route 73 n; bldg 50, ste 100; marlton, NJ 08053 ; 6174359098
• MDR Report Key: 18610952
• MDR Text Key: 334139235
• Report Number: 3012563838-2024-00005
• 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: 01/30/2024

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: H5052
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male