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

Model Number	CD3231-40
Medical Device Problem Codes	High impedance (1291); Loose or Intermittent Connection (1371); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2017865-2023-45273
• Device Sequence Number: 12416671
• Product Code: NIK
• UDI-Device Identifier: 05414734504362
• UDI-Public: 05414734504362
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2022
• 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 Sex: Unknown