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U.S. Department of Health and Human Services

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

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MEDTRONIC AMPLIA MRT QUAD CRT-D PROGRAMMER, PACEMAKER Back to Search Results
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.

 
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Brand NameAMPLIA MRT QUAD CRT-D
Type of DevicePROGRAMMER, PACEMAKER
Manufacturer (Section D)
MEDTRONIC
MDR Report Key7316178
MDR Text Key101651837
Report NumberMW5075650
Device Sequence Number1
Product Code KRG
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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 Received03/05/2018
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberDTMB1Q1
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 03/05/2018 Patient Sequence Number: 1
Treatment
OTC MEDS: NA; RX MEDS: DO NOT CURRENTLY HAVE THAT INFORMATION WITH ME, CAN OBTAIN.
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