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

Model Number 1488T

Device Problem Failure to Capture (1081)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Technical services received a call on 07/05/2012 from sales rep.The lead was implanted on (b)(6) 2006, remains implanted.Clinician saw patient in follow-up earlier in week or last week and reported to rep.Today that atrial lead had loc.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: 17533211
• MDR Text Key: 321200046
• Report Number: MW5140115
• 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

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 1488T
• Patient Sequence Number: 1