MAUDE Adverse Event Report: PACESETTER PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number 1488TC

Device Problems Failure to Sense (1559); Low impedance (2285)

Patient Problems Atrial Fibrillation (1729); Foreign Body In Patient (2687)

Event Date 07/05/2012

Event Type  Injury  

Event Description

This lead was implanted on (b)(6) 2005 and capped on (b)(6) 2012 due to low impedance issues with no sensing and atrial fibrillation.The procedure took place 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): PACESETTER
• MDR Report Key: 17537245
• MDR Text Key: 321143739
• Report Number: MW5144125
• 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: 08/10/2012

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?: No
• Device Model Number: 1488TC
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1