MAUDE Adverse Event Report: MEDTRONIC, INCORPORATED DEFIBRILATOR/PACEMAKER; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTPA2QQ

Device Problem Device Alarm System (1012)

Patient Problem Insufficient Information (4580)

Event Date 04/01/2023

Event Type  malfunction  

Event Description

Defibrillator sounding alarm sound.

• Brand Name: DEFIBRILATOR/PACEMAKER
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC, INCORPORATED
• MDR Report Key: 16684015
• MDR Text Key: 312935875
• Report Number: MW5116355
• Device Sequence Number: 1
• Product Code: NIK
• 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
• Type of Report: Initial
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DTPA2QQ
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ASPIRIN, PEPCID, CRANBERRY PILLS.; MEDTRONIC COBALT XT DEFIB / PACEMAKER, BUMEX, ASPIRIN, ALLOPURINOL, CARVEDILOL, VIT D, LANTUS, VICTOZA, HYDRALAZINE, IMDUR, CRESTOR, PEPCID.
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White