MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL AMPLIA MRI CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTMB1D1

Device Problem Pacing Problem (1439)

Patient Problems Bradycardia (1751); Fall (1848)

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 511212, lead, implanted: (b)(6) 2014.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient had presented after having fallen.The cardiac resynchronization therapy defibrillator (crt-d) was suspected to not be functioning as the patient's heart rate was noted to be lower than the device's programmed lower pacing rate of fifty beats per minute.The crt-d remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: AMPLIA MRI CRT-D SURESCAN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 11508112
• MDR Text Key: 241433376
• Report Number: 9614453-2021-01057
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00763000059606
• UDI-Public: 00763000059606
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2021
• Device Model Number: DTMB1D1
• Device Catalogue Number: DTMB1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/17/2021
• Date Device Manufactured: 02/06/2020
• 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: 75 YR
• Patient Weight: 75