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 11/30/2023

Event Type  Injury  

Manufacturer Narrative

The explanted device passed electronic controls testing and no anomalies were present during evaluation other than a set screw being removed.It is suspected that the set screw during initial implantation was not properly torqued down, which would explain the "asymetric_pulses" and impedance errors the device exhibited during previous interrogations.Thus, the issue is attributable to improper surgical technique.

Event Description

On (b)(6) 2023, a patient reported to the impulse dynamics hotline that their implanted optimizer smart mini device would not charge after multiple attempts.The patient reported that their charger would emit three beeps before displaying an error code.The patient's !pg was reset and interrogated by a member of impulse dynamics field staff.The interrogation revealed both !pg leads had impedance greater than 2000 ohms, and the cause of the device entering down mode and unable to be charged was a "therapy error: down_asymetric_pulses".Upon reset, the !pg was able to deliver ccm therapy appropriately and be charged despite the presence of premature ventricular contractions.The patient was sent home and advised to call back if the error persisted.On (b)(6) the patient requested a follow-up to be seen for their ipg to again be reset.On (b)(6) the patient contacted the impulse dynamics hotline to again report an error code being displayed on their charger attributable to the ipg reverting to down mode.The ipg was reset again on december 4 and was shown to be delivering therapy appropriately despite both lead impedance readings remaining greater than 2000 ohms.However, due to these recurrent problems, a revision surgery was scheduled and occurred on december 14.The patient was reportedly doing well post-op, and the explanted ipg was sent to impulse dynamics usa, inc.For further examination.

• 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: 18414311
• MDR Text Key: 331582406
• Report Number: 3012563838-2023-00020
• 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: 12/28/2023

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: Lay User/Patient
• Device Model Number: CCM X11
• Device Catalogue Number: 10-B501-3-XX
• Device Lot Number: H4881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Sex: Male