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

Model Number CDDRA500Q

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Convert Rhythm (1540)

Patient Problem Arrhythmia (1721)

Event Date 10/09/2023

Event Type  Injury  

Event Description

It was reported, that the patient presented remotely via merlin.Net.Review of the transmission revealed, that the implantable cardioverter defibrillator delivered appropriate shock therapy.The electrogram (egm) from the remote transmission did not reflect the therapy delivered.It was unknown, whether the therapy successfully converted the arrhythmia or if it resolved on its own, due to the missing data.No intervention was performed.The patient was stable.

Manufacturer Narrative

The reported event of the egms were not visible following an event where therapy was delivered was confirmed.Following the review of the session records, it was found that an segm was not stored, but the cause was not able to be determined without a device image.

• 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: 18025816
• MDR Text Key: 326790981
• Report Number: 2017865-2023-50916
• 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
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDDRA500Q
• Device Lot Number: P000158652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2022
• 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/52 TENDRILLEADS; LDA220Q/65 OPTISURE MRI LEADS
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Male