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

Model Number CDHFA500Q

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930)

Event Date 04/01/2024

Event Type  Injury  

Manufacturer Narrative

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.Review of the sterilization records confirmed normal sterilization cycles for the products.The product was returned, and visual inspection was normal.Interrogation of the device revealed it was above elective replacement indicator (eri) when received.The cause of infection could not be traced to the device.

Event Description

It was reported that the patient presented with pocket infection.The whole system was explanted and replaced.Patient status was not known.

Event Description

New information received notes intermittent hypotension was encountered when attempting to remove the right ventricular (rv) lead during a procedure to explant the system for infection and had to pause in order for blood pressure (bp) to recover.Damage seemed to have occurred during the procedure and an emergency sternotomy with cardiopulmonary bypass for cardiogenic shock had to be performed.No bleeding was in the pericardium, but the heart was fibrillating requiring a cardiac massage.The bp was brought back up, drugs were given, and the heart shocked back into rhythm, the patient was hemodynamically stable after his point.The rv lead was then successfully extracted with the lv lead.The patient experienced coldness but was warmed up.The procedure continued and the patient was taken to the intensive care unit (icu) for recovery.

Manufacturer Narrative

Interrogation of the device revealed it was above elective replacement indicator (eri) when received.Based on this information, the device was found to communicate appropriately with a merlin programmer and has not reached the elective replacement indicator (eri).A device history record (dhr) review was performed, and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.Review of the sterilization records confirmed normal sterilization cycles for the products.The cause of infection could not be determined.

• Brand Name: GALLANT HF
• 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: 19113287
• MDR Text Key: 340224419
• Report Number: 2017865-2024-38475
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032010
• UDI-Public: (01)05415067032010(10)P000152989(17)240831
• 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
• Report Date: 05/03/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: CDHFA500Q
• Device Lot Number: P000152989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2022
• 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
• Treatment: DURATA ACTIVE; QUARTET; RIGHT ATRIAL LEAD
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male