MAUDE Adverse Event Report: IMPULSE DYANMICS OPTIMIZER SMART MINI; IMPLANTABLE PULSE GENERATOR

Model Number 10-B501-3-XX

Device Problem Device Dislodged or Dislocated (2923)

Event Date 08/03/2023

Event Type  Injury  

Manufacturer Narrative

The associated complaint remains under investigation.

Event Description

On (b)(6) 2023, impulse dynamics received an fda medwatch alert that an optimizer implantable pulse generator (ipg) device., "was part of a system revision due to infection.There were no additional adverse patient effects reported.The device was explanted." further investigation revealed this report is tied to a complaint received on (b)(6) 2023 of a patient that was initially implanted with an optimizer smart mini ipg device on (b)(6) 2023.The patient was admitted to the hospital on (b)(6) 2023 with bacteremia; a pocket infection was suspected.It was also reported that the patient had been experiencing lower than normal cardiac contraclility modulation (ccm) therapy delivery.Fluoroscopy performed on (b)(6) 2023 confirmed ipg lead dislodgement, causing the low therapy delivery.The smart mini ipg and connected leads were explanted on (b)(6) 2023.The ipg and leads were discarded after removal.A review of the device history record (dhr) of the ipg was conducted and found no anomalies.The device was sterilized per procedure and implanted within the required expiry period.A review of the device registration record revealed no indication that a concomitant device was also implanted in the patient.The suspected cause of the lead dislodgement is improper surgical placement and/or user technique; however, the complaint remains under investigation.

• Brand Name: OPTIMIZER SMART MINI
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): IMPULSE DYANMICS; 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: 17886645
• MDR Text Key: 325114766
• Report Number: 3012563838-2023-00001
• 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: 10/05/2023

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 Expiration Date: 09/07/2023
• Device Model Number: 10-B501-3-XX
• Device Lot Number: H4733
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Male