MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC; IMPLANTABLE PACEMAKER PULSE-GENERATOR

Model Number MDT-UNKNOWN

Device Problems Signal Artifact/Noise (1036); Electromagnetic Interference (1194); Over-Sensing (1438)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

This information is based entirely on a press release in the (b)(6).All information provided is included in this report.Patient information is limited due to confidentiality concerns.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported in a news article that a search found two reports of heart devices that were suspected of experiencing electromagnetic interference.No further information was made available.The device disposition is unknown.No patient complications have been reported as a result of this event.

• Brand Name: MEDTRONIC
• Type of Device: IMPLANTABLE PACEMAKER PULSE-GENERATOR
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 12342292
• MDR Text Key: 267264025
• Report Number: 2182208-2021-03297
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDT-UNKNOWN
• Device Catalogue Number: MDT-UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1