MAUDE Adverse Event Report: ST. JUDE MEDICAL PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number CD2231-40Q

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Information received noted that the patient is alleging the implantable cardioverter defibrillator (icd) is not working.It was noted that it could be a possible ¿dead battery¿ and that it is firing.It was also noted that the device is a competitor product.Information received includes details related to a non-(b)(6) product.An email was sent to rs mdr product events to request addition of this event to the fda competitor reporting list of reported performance of competitor product.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 18038264
• MDR Text Key: 327238971
• Report Number: MW5147462
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CD2231-40Q
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention