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

Model Number DTMB2QQ

Device Problems Mechanical Problem (1384); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2019

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 right atrial (ra) lead dislodged 3 days post implant and a revision was necessary.During the revision, the physician stated there was a problem with the wrench and connection with the set screw and it was not possible to fixate the atrial lead.A new wrench was used but there was no change.The physician stated there was a problem with the grommet.It was also noted there was an issue with the right ventricular (rv) lead connection as the setscrew had dislodged from the header.The device was explanted and replaced.The ra lead was repositioned and remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AMPLIA MRI QUAD CRT-D
• 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 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8504536
• MDR Text Key: 141618375
• Report Number: 9614453-2019-01209
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2020
• Device Model Number: DTMB2QQ
• Device Catalogue Number: DTMB2QQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2019
• Initial Date FDA Received: 04/11/2019
• Supplement Dates Manufacturer Received: 04/11/2019; 06/12/2019
• Supplement Dates FDA Received: 04/11/2019; 06/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2018
• 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
• Treatment: 5076-52 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention