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 01/15/2024

Event Type  malfunction  

Event Description

It was reported that the patient exhibited difficulty in pairing their implantable cardioverter defibrillator (icd) to the merlin app.Upon further investigation, it was found that the icd exhibited loss of bluetooth telemetry functionality.No changes were reported.Here were no patient consequences.

Event Description

New information received notes the patient was brought into clinic and the device bluetooth was successfully reset, resulting in successful pairing.There were no patient consequences.

Manufacturer Narrative

The reported event of ble anomaly on the implantable cardioverter defibrillator (icd) was not confirmed.The device records were reviewed for analysis and found the device had ble lockout which is normal device function.Electrical, mechanical, and longevity analysis was normal with no anomalies found.

• 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: 18697093
• MDR Text Key: 335265012
• Report Number: 2017865-2024-22482
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Followup,Followup
• Report Date: 04/24/2024

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 Expiration Date: 05/31/2024
• Device Model Number: CDDRA500Q
• Device Lot Number: S000086972
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 02/13/2024; 04/24/2024
• Supplement Dates FDA Received: 02/21/2024; 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/02/2022
• 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; RIGHT VENTRICULAR (RV) LEAD
• Patient Age: 62 YR
• Patient Sex: Male