MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY ASSURA CRT-D RF HV; NO MATCH

Model Number CD3357-40Q

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problem Discomfort (2330)

Event Date 12/28/2023

Event Type  malfunction  

Event Description

It was reported that the patient experienced a "feeling of getting hit from his pacemaker" or pain after use of a cpap (continuous positive airway pressure) machine for 40 minutes.The patient was advised to refer to their physician.

Manufacturer Narrative

Further information was not currently available.

Event Description

New information received notes the patient had a visit in clinic (b)(6) 2024.The patient's system was checked, and all was fine.The only thing observed was intrinsic premature ventricular contractions.The patient had a subsequent visit in clinic as well on (b)(6) 2024 where the system including device was checked again and there was no malfunction, everything worked fine.The patient had no complaint and was doing well.

• Brand Name: UNIFY ASSURA CRT-D RF HV
• Type of Device: NO MATCH
• 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: 18522639
• MDR Text Key: 333089684
• Report Number: 2017865-2024-01316
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508216
• UDI-Public: 05414734508216
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: CD3357-40Q
• Device Lot Number: A000094182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2023
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2020
• 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: CPAP MACHINE; DURATA TACHY MRI LEAD; QUICKFLEXMICRO; TENDRIL STS
• Patient Age: 76 YR
• Patient Sex: Male