MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ASSERT-IQ¿ ICM; RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITHOUT ARRHYTHMIA DETECTION)

Model Number DM5500

Device Problems Migration or Expulsion of Device (1395); Under-Sensing (1661); Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2023

Event Type  malfunction  

Event Description

It was reported that the insertable cardiac monitor (icm) exhibited a decreased in r waves.The decreased in r waves may be due to the device migrating from its original position.No intervention was performed.There were no patient consequences.

Manufacturer Narrative

Further information was requested but not received.

Manufacturer Narrative

Correction: the correct statement in section b5 should have been "it was reported that the patient presented remotely via merlin.Net.Insertable cardiac monitor (icm) exhibited a decreased in r waves and resulted in under-sensing.The decreased in r waves may be due to the device migrating from its original position.Programming changes were made.There were no patient consequences.", rather than "it was reported that the insertable cardiac monitor (icm) exhibited a decreased in r waves.The decreased in r waves may be due to the device migrating from its original position.No intervention was performed.There were no patient consequences." medical device problem code should have been "under-sensing", rather than "device sensing problem".The impact code should have been "unexpected medical intervention", rather than "no health consequences or impact".The correct customer's name should have been "dawn baer", rather than "adel mina".The correct occupation should have been "nurse", rather than "physician.".

Event Description

It was reported that the patient presented remotely via merlin.Net.Insertable cardiac monitor (icm) exhibited a decreased in r waves and resulted in under-sensing.The decreased in r waves may be due to the device migrating from its original position.Programming changes were made.There were no patient consequences.

• Brand Name: ASSERT-IQ¿ ICM
• Type of Device: RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITHOUT ARRHYTHMIA DETECTION)
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18298978
• MDR Text Key: 330116626
• Report Number: 2017865-2023-94362
• Device Sequence Number: 1
• Product Code: MXC
• UDI-Device Identifier: 05415067047809
• UDI-Public: 05415067047809
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K230286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DM5500
• Device Lot Number: S000091322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• 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 Age: 74 YR
• Patient Sex: Female