MAUDE Adverse Event Report: MEDTRONIC AMPLIA MRT QUAD CRT-D; PROGRAMMER, PACEMAKER

Model Number DTMB1Q1

Device Problems Defibrillation/Stimulation Problem (1573); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Death (1802)

Event Date 11/11/2017

Event Type  Death  

Event Description

Husband had medtronic amplia mri quad crt-d installed on (b)(6) 2017 (replaced older icd); he died on (b)(6) 2017; his device did not shock him back, took 15 minutes before it went off.I have the device, removed by funeral home and i had diagnostics ran and have report from that.I was told his body just shut down.Now i have learned of fda warning that this device had manufacturing error preventing electrical shock delivery.I need answers please.

• Brand Name: AMPLIA MRT QUAD CRT-D
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 7316178
• MDR Text Key: 101651837
• Report Number: MW5075650
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DTMB1Q1
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: NA; RX MEDS: DO NOT CURRENTLY HAVE THAT INFORMATION WITH ME, CAN OBTAIN.
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Weight: 75