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

Model Number CCM X11

Device Problem Failure to Charge (1085)

Patient Problem Failure of Implant (1924)

Event Date 03/04/2024

Event Type  malfunction  

Event Description

On march 4, 2024, a representative for a distributor of impulse dynamics products outside of europe and the united states informed an impulse dynamics germany representative of a problem with an optimizer smart mini (osm) implantable pulse generator (ipg).The distributor representative attempted to update the software of a patient's implanted ipg, but the update failed due to an a9 error and the ipg battery having been depleted.Interrogation of the device yielded a "telemet error: down_ temp integrity" a9 error.Connection was unable to be established between the paired charger and the ipg, and attempts to blind-charge the device yielded the same a9 error before the device would again shut down.After this, field staff attempted to reset the device using an intelio programmer, but again the device yielded the same a9 error when blind-charging was attempted.Analysis of the ipg log files indicated the device could possibly have a hardware issue.The tentative recommendation of impulse dynamics staff, to be conferred with the implanting physician, is the removal and replacement of the device.An explant procedure has not yet been scheduled at this time.

Event Description

This is a follow-up to a previously filed mdr.On may 7, 2024, a representative for a distributor of impulse dynamics products outside of europe and the united states informed representatives from impulse dynamics germany and usa that this device had been explanted and replaced with a new osm ipg.The distributor representative also informed id staff that, according to new laws passed in their country, medical devices can no longer be sent outside the country for any reason.Without the device being available for a full evaluation, it will not be possible to definitively conclude the reason(s) why the device could previously not be charged.

• 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: 19046207
• MDR Text Key: 340115110
• Report Number: 3012563838-2024-00015
• 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: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2024

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 Model Number: CCM X11
• Device Catalogue Number: 10-B501-3-XX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2024
• 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): Other