MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) RIATA PASSIVE FIXATION; Permanent defibrillator electrodes

Model Number 1570/65

Device Problems Fracture (1260); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285)

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

Event Date 03/19/2024

Event Type  Injury  

Event Description

It was reported that a patient presented with inappropriate shock due to possible emi on the implantable cardioverter defibrillator (icd) and right ventricular (rv) lead.It was also noted that the rv lead exhibited low pacing impedance.Rv lead fracture was suspected.No changes or interventions were reported.The patient condition was unstable.

• Brand Name: RIATA PASSIVE FIXATION
• Type of Device: Permanent defibrillator electrodes
• 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: 19079553
• MDR Text Key: 339821886
• Report Number: 2017865-2024-38103
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734005302
• UDI-Public: (01)05414734005302(10)2483453(17)090131
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2024

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: 01/31/2009
• Device Model Number: 1570/65
• Device Lot Number: 0002483453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/18/2006
• 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
• Patient Outcome(s): Other