MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT DR; NO MATCH

Model Number CDDRA500Q

Device Problem Product Quality Problem (1506)

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

Event Date 09/27/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented for routine implant of the implantable cardioverter defibrillator.During the procedure the intended implant device was observed to have a cloudy header.The device was not implanted, and the procedure was completed with a replacement.The patient was stable.

Manufacturer Narrative

Correction: the reported event of header discoloration was confirmed.However, the cloudy appearance was found to be acceptable since all the header components and the tip of the test leads were visible through the header.Interrogation of the device revealed the device was above the elective replacement indicator (eri) when received.The device was tested on the bench with leads and resistor loads.Telemetry, sensing, pacing, low voltage impedance, high voltage (hv) impedance, patient notification, and hv shock were tested.No anomaly was detected.A device history record (dhr) review was performed and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

Manufacturer Narrative

The reported event of header discoloration was confirmed.However, the cloudy appearance was found to be acceptable since all the header components and the tip of the test leads were visible through the header.Interrogation of the device revealed the device was above the elective replacement indicator (eri) when received.The device was tested on the bench with leads and resistor loads.Telemetry, sensing, pacing, low voltage impedance, high voltage (hv) impedance, patient notification, and hv shock were tested.No anomaly was detected.

• Brand Name: GALLANT DR
• 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: 17949655
• MDR Text Key: 325900465
• Report Number: 2017865-2023-49990
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032003
• UDI-Public: 05415067032003
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2023

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 Model Number: CDDRA500Q
• Device Lot Number: A000144637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/27/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 11/11/2023; 12/04/2023
• Supplement Dates FDA Received: 11/29/2023; 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2023
• 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: 43 YR
• Patient Sex: Female
• Patient Weight: 147 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American