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

Model Number DTMB1Q1

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 12/08/2021

Event Type  malfunction  

Event Description

It was reported that the cardiac resynchronization therapy defibrillator (crt-d) exhibited a gray bar indicating battery voltage below indication for implant.The device was left inside to recover for seven days.After waiting the seven days, the device was re-interrogated and a gray bar was still observed.The device was not implanted.There was no patient involvement.

Manufacturer Narrative

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

• Brand Name: AMPLIA MRI QUAD 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: 13118087
• MDR Text Key: 282967074
• Report Number: 9614453-2021-04776
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00763000059682
• UDI-Public: 00763000059682
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/30/2021

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: Other
• Device Expiration Date: 12/28/2021
• Device Model Number: DTMB1Q1
• Device Catalogue Number: DTMB1Q1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 12/30/2021
• Date Device Manufactured: 06/29/2020
• 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