MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Assert-IQ¿ ICM; Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)

Model Number	DM5500
Medical Device Problem Codes	Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's insertable cardiac monitor (icm) was suspected to exhibit premature battery depletion due to an incorrect measurement of battery longevity that later returned to its appropriate value.Afterwards, it was noted that icm exhibited premature elective replacement indicator (eri) and was confirmed to exhibit early battery depletion.The icm was explanted and replaced.The patient had no consequences due to the event.
Additional Manufacturer Narrative
The reported complaint of premature battery depletion was confirmed.Based on the information provided, it was determined there was unexpected increase in the current drain and drop in the battery voltage, resulting in battery depletion.The root cause of the unexpected increase in current drain and drop in voltage could not be determined with the available data.

• Brand Name: Assert-IQ¿ ICM
• Common Device Name: Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
• Manufacturer (Section D): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 50947602
• Report Number: 2017865-2026-20715
• Device Sequence Number: 13349385
• Product Code: MXC
• UDI-Device Identifier: 05415067047809
• UDI-Public: (01)05415067047809(10)S000092892(17)250608
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K230286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/08/2025
• Device Model Number: DM5500
• Device Lot Number: S000092892
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male