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

Model Number CD2411-36Q

Device Problems Failure to Deliver Shock/Stimulation (1133); Over-Sensing (1438)

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

Event Date 03/30/2024

Event Type  Injury  

Event Description

It was reported a patient's implantable cardioverter defibrillator (icd) presented with non-sustained right ventricular oversensing (nsrvo) alerts for slow ventricular tachycardia (vt) in a monitor zone.No changes were reported.The patient was stable.

Manufacturer Narrative

Further information requested but not received.

Manufacturer Narrative

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

Event Description

New information received notes programming changes were made on the implantable cardioverter defibrillator (icd) to restore normal parameters.The patient required high voltage therapy since the ventricular tachycardia (vt) fell below the monitor zone.External high voltage therapy was used to resolve the event.The patient was stable.

• 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: 19166375
• MDR Text Key: 340974697
• Report Number: 2017865-2024-39423
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507615
• UDI-Public: (01)05414734507615(10)S000074561(17)211231
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2024

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: 12/31/2021
• Device Model Number: CD2411-36Q
• Device Lot Number: S000074561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/06/2020
• 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
• Patient Age: 89 YR
• Patient Sex: Male