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

Model Number CD2357-40C

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

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

Event Date 10/13/2023

Event Type  Injury  

Event Description

Related manufacturer reference number: 2017865-2023-51119.It was reported that patient presented to emergency room after experiencing in appropriate shock from implantable cardioverter defibrillator (icd).Upon interrogation, it was found that the icd failed capacitor maintenance due to long charge time.It was also noted that patient's atrial lead exhibited high threshold.Programming changes were made.The patient was stable.

Event Description

New information received notes that patient received inappropriate shock due to incorrect interpretation of signal from patient's implantable cardioverter defibrillator (icd).

• Brand Name: FORTIFY ASSURA DR ICD, US
• 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: 18031157
• MDR Text Key: 326867389
• Report Number: 2017865-2023-51118
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734508063
• UDI-Public: 05414734508063
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2023

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: 09/30/2015
• Device Model Number: CD2357-40C
• Device Lot Number: 4284057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 11/03/2023
• Supplement Dates FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2013
• 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
• Patient Age: 76 YR
• Patient Sex: Male