MAUDE Adverse Event Report: MEDTRONIC, INC. ADVISA DR MRI PACEMAKER; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number A2DR01

Device Problems Failure to Capture (1081); Fracture (1260); High impedance (1291); Pacing Intermittently (1443)

Patient Problems Failure of Implant (1924); Hot Flashes/Flushes (2153); Dizziness (2194)

Event Date 06/06/2022

Event Type  Injury  

Event Description

Telemetry at emergency department documented episodes of ventricular pacing output with loss of capture, associated with patient's clinical symptoms of feeling hot and flushed with lightheadedness and dizziness.One impedance measurement elevated at over 3000 ohms in both bipolar and unipolar mode.He likely has a an early conductor coil fracture of both coils of his coaxial ventricular lead with intermittent loss of pacing output.Right atrial lead and battery function normal.Left ventricular lead programmed to unipolar pacing and bipolar sensing.Temporary active-fixation pacing lead placed yesterday.Telemetry shows 2 episodes overnight of loss of capture of the permanent pacing lead with subsequent backup pacing at 50 bpm by the temporary lead.Plan for placement of new rv lead tomorrow.Fda safety report id # (b)(4).

• Brand Name: ADVISA DR MRI PACEMAKER
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 14914657
• MDR Text Key: 295359864
• Report Number: MW5110656
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2018
• Device Model Number: A2DR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 51 KG