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

Model Number 10-B501-3-XX

Device Problem Failure to Deliver Energy (1211)

Patient Problem Failure of Implant (1924)

Event Date 09/11/2023

Event Type  malfunction  

Event Description

On september 11, 2023, impulse dynamics received an fda medwatch alert of a report that an optimizer smart mini implantable pulse generator (ipg) continuously failed to fully charge.The patient complained that they had a "difficult time breathing comfortably" and that the ipg charger produced an a09 error code.This report is tied to 7 complaints that impulse dynamics is currently investigating.Documented in these complaints is a "temperature integrity" a09 error code that kept causing the ipg to enter down mode.Prior resolution of the issue was achieved by having the patient's device reset, but due to the continuous re-occurrence of the issue, a revision surgery has been scheduled.

Manufacturer Narrative

The associated complaints remain under investigation.A capa has been opened to further investigate and resolve the issue.

• 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 08054
• Manufacturer Contact: robert fasciano ; 401 route 73 n; bldg 50, ste 100; marlton, NJ 08054 ; 6174359098
• MDR Report Key: 17917017
• MDR Text Key: 325848738
• Report Number: 3012563838-2023-00002
• Device Sequence Number: 1
• Product Code: QFV
• UDI-Device Identifier: 00810003380098
• UDI-Public: 00810003380098
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180036/S007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2023
• Device Model Number: 10-B501-3-XX
• Device Lot Number: H4683
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 10/11/2023
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White