MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. EVERA MRI XT DR SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number DDMB1D4

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

Patient Problem Distress (2329)

Event Date 07/11/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient's implantable cardioverter defibrillator (icd) exhibited an alert tone.The patient was emotionally distressed as they did not know why the alert was sounding and could not reach the clinic for further instructions.Subsequent follow-up with the patient's clinic revealed the patient had likely encountered a magnet.The icd remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: EVERA MRI XT DR SURESCAN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8852484
• MDR Text Key: 162809195
• Report Number: 3004209178-2019-14825
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00643169720497
• UDI-Public: 00643169720497
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/14/2020
• Device Model Number: DDMB1D4
• Device Catalogue Number: DDMB1D4
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/11/2019
• Date Device Manufactured: 02/20/2019
• 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
• Patient Age: 58 YR