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

Model Number DTMB1D1

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Septic Shock (2068)

Event Date 10/23/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported the by patient's family member that the patient is deceased and died approximately two and a half weeks post device changeout.The patient is reported to have had an infection and septic shock.It was further reported that the device ¿didn¿t work¿during a ¿code¿.Additional information was requested and not received.

• 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: 10906240
• MDR Text Key: 218484623
• Report Number: 3004209178-2020-20658
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169837690
• UDI-Public: 00643169837690
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/28/2020
• Device Model Number: DTMB1D1
• Device Catalogue Number: DTMB1D1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2020
• Date Device Manufactured: 07/12/2019
• 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 Outcome(s): Death
• Patient Age: 67 YR