MAUDE Adverse Event Report: ST. JUDE MEDICAL/ ABBOTT LABORATORIES CARDIO MEMS AND ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/11/2020

Event Type  malfunction  

Event Description

Fluid buildup requiring weeks in hospital got diuretics.There is no data.That¿s the complaint.Fda safety report id # (b)(4).

• Brand Name: CARDIO MEMS AND ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL/ ABBOTT LABORATORIES
• MDR Report Key: 9733441
• MDR Text Key: 180632016
• Report Number: MW5093120
• Device Sequence Number: 2
• Product Code: LWS
• 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: 02/14/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 98