MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. AMPLIA MRI CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTMB1D4

Device Problem Output Problem (3005)

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

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the device was returned and analyzed.The actual longevity was less than 80 of the 99.9 longevity limit.The device was fully functional, with no high current drain or evidence of battery problems.Without the history of the programmed settings throughout its service life, there is no way to determine why the longevity did not match the predicted model.Concomitant medical products: 6935m62, lead implanted: (b)(6) 2017; 6935m62 lead implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.

Event Description

The cardiac resynchronization therapy defibrillator (crt-d) was explanted and replaced due to the battery reaching elective replacement indicator (eri).The device was returned to the manufacturer, analyzed, and tested out of specification.No 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 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: 12345827
• MDR Text Key: 267468946
• Report Number: 3004209178-2021-12681
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169543430
• UDI-Public: 00643169543430
• 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: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/14/2018
• Device Model Number: DTMB1D4
• Device Catalogue Number: DTMB1D4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Date Manufacturer Received: 07/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2017
• 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: 73 YR