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

Model Number CCM X10

Device Problem Impedance Problem (2950)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 12/05/2023

Event Type  Death  

Event Description

On (b)(6) 2023, a patient implanted with an optimizer smart ipg device contacted impulse dynamics customer service to report they received an error code 1 (detected change in electrical impedance of the leads) while attempting to charge the device.The patient informed cs that they were in the hospital and had been cardioverted the day before (november 30) due to atrial fibrillation.Impulse dynamics field staff contacted the patient and asked them to wait 24 hours before attempting to charge again, and to reach out if the error code persisted.Follow-up communication attempts with the patient by id field staff on december 3 and 4 went unanswered, but on (b)(6), the implanting physician informed id field staff that the patient had been in the icu after being implanted with an lmpella left ventricular assist device.When id field staff arrived at the icu later that day to interrogate the smart ipg, they were informed that the hospital staff had to cardiovert the patient twice, but the patient subsequently coded and had to be resuscitated.Upon interrogation of the smart ipg, the device was found to be in magnet mode, attributable from a magnet having been placed over the device during one of the cardioversions.In addition, the ipg was not able to deliver therapy due to the ls signal having shifted, again attributable to cardioversion and resuscitation attempts.The physician informed id field staff that the prognosis for the patient was "not good" and not to worry about ccm therapy at that point.The ipg was left on but with the therapy delivery function disabled.On (b)(6), the physician notified id field staff that the patient had expired after family members chose to initiate the dnr protocol.

Manufacturer Narrative

There is no evidence at this time to suggest the patient's smart ipg caused or contributed to the heart failure leading to death.However, the alert code present during ipg charging leading up to the patient's death remains a reportable event based on the criteria outlined in the fda "guidance for industry and staff: medical device reporting for manufacturers" issued on november 8, 2016.

• Brand Name: OPTIMIZER SMART
• 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: 18450007
• MDR Text Key: 332169408
• Report Number: 3012563838-2024-00001
• Device Sequence Number: 1
• Product Code: QFV
• Combination Product (y/n): N
• PMA/PMN Number: P180036
• 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: 01/04/2024

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 Expiration Date: 03/21/2024
• Device Model Number: CCM X10
• Device Catalogue Number: 10-B411-3-XX
• Device Lot Number: H4796
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• 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
• Treatment: BIOTRONIK DR DEFIBRILLATOR.; IMPELLA LEFT VENTRICULAR ASSIST DEVICE.
• Patient Outcome(s): Death
• Patient Sex: Male