MAUDE Adverse Event Report: MEDTRONIC, INC. EVERA; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Device Problems Fracture (1260); Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 07/25/2017

Event Type  Injury  

Event Description

Multiple unnecessary shocks, medtronic evra (b)(4), sprint quattro lead fracture, impedance, insertion of reveal linq without consent / knowledge.Sent home with a wires e-devices made in (b)(4) and a bedside "my care link" monitor that alarmed non-stop required explanation.Reported before, yet advisory claims no issues.No notice from medtronic or mfr.Never shown a label from any device.Never warned of potential or actual problems.Believes my care link software was hacked.Was this device serviced by a third party servicer? yes.Fda safety report id# (b)(4).

• Brand Name: EVERA
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 8671395
• MDR Text Key: 147240894
• Report Number: MW5087131
• Device Sequence Number: 1
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/30/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 33 YR
• Patient Weight: 82