MAUDE Adverse Event Report: NUCLEAR STRESS TEST

Device Problem Insufficient Information (3190)

Patient Problem Myocardial Infarction (1969)

Event Date 09/04/2016

Event Type  Injury  

Event Description

Was given a nuclear stress test and, within a period of 6 weeks, had a heart attack.I was given an all clear and beautifully clear arteries after the test.

• Brand Name: NUCLEAR STRESS TEST
• Type of Device: NUCLEAR STRESS TEST
• MDR Report Key: 5952388
• MDR Text Key: 54935712
• Report Number: MW5064768
• Device Sequence Number: 1
• Product Code: DQK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ASPIRIN; CRESTOR; METFORMIN; OTC MEDS: FISH OIL; RX MEDS: LISINOPRIL
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 75