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

Model Number CDDRA500Q

Device Problem Failure to Charge (1085)

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

Event Type  Injury  

Event Description

It was reported that the implantable cardioverter defibrillator (icd) exhibited a shorted output stage detection (sosd) during a capacitor maintenance.No changes or intervention was performed.The patient condition was stable.

Event Description

New information indicates that the implantable cardioverter defibrillator (icd) was explanted and replaced on (b)(6) 2022.The patient condition was stable before, during, and afterwards.

Manufacturer Narrative

The reported event of shorted output stage detection (sosd) was confirmed via review of the device data.However, the reported anomaly could not be reproduced in the lab.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.The cause of the sosd could not be conclusively determined.

• Brand Name: GALLANT DR
• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15331877
• MDR Text Key: 305282844
• Report Number: 2017865-2022-22016
• 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: 11/01/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: CDDRA500Q
• Device Catalogue Number: CDDRA500Q
• Device Lot Number: P000134049
• 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: 08/19/2022
• Initial Date FDA Received: 08/31/2022
• Supplement Dates Manufacturer Received: 09/02/2022; 10/20/2022
• Supplement Dates FDA Received: 09/12/2022; 11/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2021
• 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: 2088TC/52 TENDRILLEADS; 7122Q/65 DURATATACHY MRI LEADS
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male