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

Model Number	CCM X11
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the implantation of an optimizer lite (ol) implantable pulse generator, it was determined that the patient's leads required intraoperative adjustment.The surgeon retracted the set screws of the v1 and v2 leads, but upon re-engagement and tightening, the v1 lead was unable to be inserted.This was attributed to the inability of its distal set screw to be tightened.The surgeon stated "the set screw had been retracted too far and had become misaligned with the bore and threads." at that point, the device was disconnected from both leads and swapped without incident.The unused device will be returned to (b)(4) for further evaluation.

• Brand Name: OPTIMIZER LITE
• Common Device Name: 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: 20832380
• Report Number: 3012563838-2024-00038
• Device Sequence Number: 8585073
• Product Code: QFV
• UDI-Device Identifier: 00810003380142
• UDI-Public: 00810003380142
• Combination Product (Y/N): N
• PMA/510(K) Number: P180036/S021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/03/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/15/2025
• Device Model Number: CCM X11
• Device Catalogue Number: 10-B502-3-XX
• Device Lot Number: H5088
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown