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

Model Number CDDRA500Q

Device Problems Failure to Interrogate (1332); Wireless Communication Problem (3283)

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

Event Date 01/29/2024

Event Type  malfunction  

Event Description

It was reported that the implantable cardioverter defibrillator was unable to pair to the mobile application due to a suspected bluetooth malfunction.The device was eventually able to pair.No intervention was performed.There were no patient consequences.

Manufacturer Narrative

Correction - h6 - medical device problem code should have been wireless communication problem rather than failure to interrogate correction - h6 - investigation findings code should have been no device problem found rather than no findings available.

• 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: 18727744
• MDR Text Key: 335992918
• Report Number: 2017865-2024-32921
• Device Sequence Number: 1
• Product Code: NIK
• 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: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• 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: P000157375
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2022
• 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: 2088TC/46 TENDRIL STS LEADS; 7122Q/58 DURATA TACHY MRI LEADS
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 82 KG