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

Model Number CD3357-40C

Device Problems High impedance (1291); Loose or Intermittent Connection (1371)

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

Event Date 12/06/2023

Event Type  Injury  

Event Description

It was reported that the patient¿s device had an alert for high pacing impedance.On (b)(6) 2023, a pocket revision procedure was performed.The physician tightened the setscrew to check if that was the issue, once the setscrew was tightened the impedance was normal.The device remained implanted.The patient was stable and discharged post procedure.

Manufacturer Narrative

Correction: h6 - health effect - impact code should have been 4625 - additional surgery rather than 2199 - no health consequences or impact as reported in the initial mdr.

• 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: 18386913
• MDR Text Key: 331245565
• Report Number: 2017865-2023-95476
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508186
• UDI-Public: 05414734508186
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: CD3357-40C
• Device Lot Number: P000180541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2023
• 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 Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 124 KG