MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ELLIPSE DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number CD2411-36Q

Device Problems Failure to Charge (1085); Incorrect Interpretation of Signal (1543); Inappropriate/Inadequate Shock/Stimulation (1574); Delayed Charge Time (2586)

Patient Problems Arrhythmia (1721); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Further information requested but not received.

Event Description

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

Manufacturer Narrative

Additional information: b1, b2, b5, e1, e2, e3, g2, h1, h6.

Event Description

New information received notes there was an alert for charge time limit reached on the implantable cardioverter defibrillator (icd).The patient had rapid heart rates due to an electrolyte imbalance and the device delivered some appropriate shocks and some inappropriate shocks for atrial fibrillation (af) with rapid ventricular response (rvr).The patient was stable post shocks and alert.

Event Description

New information received notes the implantable cardioverter defibrillator (icd) was explanted and replaced in a procedure on (b)(6) 2023.Post-procedure the patient status was unknown.

Manufacturer Narrative

Additional information: b2, b5, d6b, h6.

• Brand Name: ELLIPSE DR
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 17819492
• MDR Text Key: 324287486
• Report Number: 2017865-2023-47031
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507615
• UDI-Public: 05414734507615
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• 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: 12/11/2023

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: 07/31/2016
• Device Model Number: CD2411-36Q
• Device Lot Number: 4737499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 09/29/2023; 11/21/2023
• Supplement Dates FDA Received: 10/12/2023; 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2014
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female