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

Model Number CD3231-40

Device Problems High impedance (1291); Loose or Intermittent Connection (1371); Connection Problem (2900)

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

Event Date 08/23/2023

Event Type  Injury  

Event Description

It was reported that a patient presented to clinic for follow up.Device interrogation revealed high pacing impedance on the right ventricular (rv) lead.The physician considers high pacing impedance is due to inadequate insertion on the implantable cardioverter defibrillator (icd) header.During repositioning, the set screw was unable to be tightened.The physician elected to explant and replace the icd.The patient condition was stable.

Manufacturer Narrative

The reported field event of lead connection issue was confirmed.Septum material was observed inside the right ventricular lead set screws hex cavity.This did not allow the set screw to be tightened and secured properly in the field, resulting in high lead impedance.The issue was consistent with having occurred during the procedure.The device was above elective replacement indicator (eri) when received.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.

• Brand Name: UNIFY CRT-D
• 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: 17765516
• MDR Text Key: 323623212
• Report Number: 2017865-2023-45273
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734504362
• UDI-Public: 05414734504362
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: CD3231-40
• Device Lot Number: A000127470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2022
• 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
• Patient Outcome(s): Required Intervention