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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. EVERA MRI XT DR SURESCAN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number DDMB1D4
Device Problems Electromagnetic Interference (1194); Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/24/2019
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported by the patient that their implantable cardioverter defibrillator (icd) has emitted a long audible alert on multiple occasions. The patient indicated that they had the device checked and sent in remote transmissions to be reviewed by their physician. The patient's physician checked the device and leads and reassured the patient that the device was working fine. Patient described what they were doing when the alerts sounded. Once playing cards, once at the computer and once while on the home phone. It was discussed that if a magnetic field is detected by the implant the long steady tone emits. Patient thought because it happened in random places it couldn't be a magnet. When the patient was asked about what they may be carrying, it was determined the patient was wearing an apple watch that has a magnetic band on it. In the three examples each activity likely resulted in their wrist being too close to the device. Patient indicated that they will be aware of the magnet tone now and replace the band with a non-magnetic option. The device remains in use. No patient complications have been reported as a result of this event.

 
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Brand NameEVERA MRI XT DR SURESCAN
Type of DeviceDEFIBRILLATOR, 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 Key8791463
MDR Text Key151118095
Report Number3004209178-2019-13549
Device Sequence Number1
Product Code LWS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP980016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 07/15/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/15/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/28/2020
Device MODEL NumberDDMB1D4
Device Catalogue NumberDDMB1D4
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/06/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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