MAUDE Adverse Event Report: MEDTRONIC TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE

Model Number UNKNOWN

Device Problem Communication or Transmission Problem (2896)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Pt advocate called in regarding questions about a medtronic teletrace pacemaker transmitter type system that pt.Has in the home.Advocate said that this transmitter is taking longer to transmit - it usually takes 3 minutes and the last few times it took 10-15 min.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE
• Type of Device: TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17534924
• MDR Text Key: 321198409
• Report Number: MW5141824
• Device Sequence Number: 1
• Product Code: DXH
• 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: 11/13/2012

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: UNKNOWN
• Patient Sequence Number: 1