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

Model Number PM2210

Device Problems Over-Sensing (1438); No Pacing (3268)

Patient Problem Cardiac Arrest (1762)

Event Type  Injury  

Event Description

This device was implanted on (b)(6) 2010.And was explanted on (b)(6) 2013, due to oversensing and pacing inhibition with asystole of less than 2 seconds.The physician was dr.(b)(6) at (b)(6).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: 17534677
• MDR Text Key: 321147362
• Report Number: MW5141577
• Device Sequence Number: 1
• Product Code: NVZ
• 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: 12/17/2013

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
• Patient Sequence Number: 1