MAUDE Adverse Event Report: ST JUDE MEDICAL / ABBOTT LABORATORIES ICD ; DEFIBRILLATOR AUTOMATED, IMPLANTABLE CARDIOVERTER WITH CARDIAC RESYNCHRONIZATION

Model Number CD3211-36Q

Device Problems Device Alarm System (1012); Nonstandard Device (1420)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/05/2020

Event Type  Injury  

Event Description

Aicd placed 2010 st.Jude generator changed second time on (b)(6) 2019.Alarms have been going off.(b)(6) clinic turned some off.My other cardiologist turned more alarms off.Medtronic told me that my leads are recalled.Never notified by company, (b)(6) clinic surgeons or electro physiologist doing the generator change.Fda safety report id# (b)(4).

• Brand Name: ICD
• Type of Device: DEFIBRILLATOR AUTOMATED, IMPLANTABLE CARDIOVERTER WITH CARDIAC RESYNCHRONIZATION
• Manufacturer (Section D): ST JUDE MEDICAL / ABBOTT LABORATORIES
• MDR Report Key: 9580901
• MDR Text Key: 175086283
• Report Number: MW5092167
• 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: 01/08/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CD3211-36Q
• 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): Required Intervention
• Patient Age: 72 YR