MAUDE Adverse Event Report: ST. JUDE MEDICAL IMPLANTABLE PACEMAKER ACCENT DR; IMPLANTABLE PACEMAKER PULSE-GENERATOR

Model Number PM2210, 511211

Device Problem Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Patient asking what materials are in his pacemaker.States "my dermatologist wants me to find out what materials are in my pacemaker"." lead manufactured by st jude.Case: (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: IMPLANTABLE PACEMAKER ACCENT DR
• Type of Device: IMPLANTABLE PACEMAKER PULSE-GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17530510
• MDR Text Key: 321345176
• Report Number: MW5137429
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: PM2210, 511211
• Patient Sequence Number: 1