MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT HF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CDHFA500Q

Device Problems Premature Discharge of Battery (1057); Failure to Capture (1081); Connection Problem (2900); Impedance Problem (2950)

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

Event Type  Injury  

Event Description

It was reported a patient's implantable cardioverter defibrillator (icd) presented with a connector anomaly.No changes were reported.The patient status was unknown.

Manufacturer Narrative

Further information requested but not received.

Manufacturer Narrative

Additional information: a4, b1, b2, b5, d6b, d9, h1, h3, h6.

Event Description

New information received notes there was an issue with the implantable cardioverter defibrillator (icd) header and all impedances were out of range.The icd battery failed and resulted in non-capture.The device was explanted and replaced in a procedure on (b)(6) 2023.Post-procedure there were no patient consequences.

Manufacturer Narrative

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.The reported event of a header connection anomaly was not confirmed.The reported event of impedance, premature depletion, and capture anomaly was confirmed.The cause of the impedance, premature depletion, and capture anomaly was due to an insufficient internal supply.The insufficient internal supply was due to an anomalous capacitor.The reported missing hvla oor was confirmed.The additional information provided was reviewed by abbott engineering.It was observed that the patient notifier was present as an alert, but the alert does not include details of the date and time of the out of range impedance.This is per device design.

Manufacturer Narrative

Correction: the reported event of a header connection anomaly was not confirmed.The reported event of impedance, premature depletion, and capture anomaly was confirmed.Electrical testing revealed low internal voltage within the hybrid.An internal hybrid anomaly was found to be the cause of the confirmed reported events.The reported missing hvla oor was confirmed.The additional information provided was reviewed by abbott engineering.It was observed that the patient notifier was present as an alert, but the alert does not include details of the date and time of the out of range impedance.This is per device design.

• Brand Name: GALLANT HF
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 16955609
• MDR Text Key: 315686444
• Report Number: 2017865-2023-20419
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032010
• UDI-Public: 05415067032010
• 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: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDHFA500Q
• Device Catalogue Number: CDHFA500Q
• Device Lot Number: P000154472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2022
• 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: ATRIAL LEAD.; LEFT VENTRICULAR LEAD.; RIGHT VENTRICULAR (RV) LEAD.
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 73 KG