MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH- MR MAGNETOM SKYRA; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 10432915

Device Problem Use of Device Problem (1670)

Patient Problems Undesired Nerve Stimulation (1980); Patient Problem/Medical Problem (2688)

Event Date 11/12/2019

Event Type  Injury  

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a user error.The system is equipped with a squeeze ball and an intercom for the patient to alert the operator in the event of experiencing discomfort.With these existing safety features, a death or serious injury is unlikely.There is a clear warning in the magnetom family operator manual - mr system syngo mr e11.In general, an mr examination is contraindicated for patients with electronic or electronically conductive implants or metals, especially those containing ferromagnetic foreign matter.Certain implantable medical devices have been cleared, approved and/or licensed by the competent governmental authorities and/or labeled by the device manufacturer as "mr conditional".It is the responsibility of the device manufacturer to declare an implantable medical device as mr conditional if appropriate and to define the conditions (constraints) for safe mr scanning.The mr operator must be aware of any such conditions for mr scanning.It is the obligation of the mr operator to assure that these conditions are strictly adhered to.To obtain these specific conditions the mr operator may refer to the labeling of the implantable medical device or contact the device manufacturer.Siemens mr does not assume responsibility or liability for the operation of the mr system with any implantable medical device.

Event Description

It was reported to siemens that an adverse event occurred while operating the magnetom skyra system.An implanted vns (vagus nerve stimulation) device heated up during the mri scan and caused a burning/glowing experience for the patient in the left thoracic area.The patient pressed the squeeze ball during or after the third measurement.No injuries were visible on the skin.After aborting the mri scan, the patient was immediately transferred to the emergency department for examination.The palpation around the implant was painful and the patient suffered swallowing problems.The patients lab and ecg were normal.The patient went home later that day with pain medication.The patient is now scheduled for surgical removal of the vns implant and lead.

Manufacturer Narrative

Correction: siemens became aware of this event on 2019-12-13 when information was provided that the patient was scheduled for surgical explantation.Siemens has completed an investigation of the reported event.The root cause was determined to be a user error.The system is equipped with a squeeze ball and an intercom for the patient to alert the operator in the event of experiencing discomfort.With these existing safety features, a death or serious injury is unlikely.There is a clear warning in the magnetom family operator manual - mr system syngo mr e11.In general, an mr examination is contraindicated for patients with electronic or electronically conductive implants or metals, especially those containing ferromagnetic foreign matter.Certain implantable medical devices have been cleared, approved and/or licensed by the competent governmental authorities and/or labeled by the device manufacturer as "mr conditional".It is the responsibility of the device manufacturer to declare an implantable medical device as mr conditional if appropriate and to define the conditions (constraints) for safe mr scanning.The mr operator must be aware of any such conditions for mr scanning.It is the obligation of the mr operator to assure that these conditions are strictly adhered to.To obtain these specific conditions the mr operator may refer to the labeling of the implantable medical device or contact the device manufacturer.Siemens mr does not assume responsibility or liability for the operation of the mr system with any implantable medical device.

• Brand Name: MAGNETOM SKYRA
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- MR; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• MDR Report Key: 9770291
• MDR Text Key: 188483472
• Report Number: 3002808157-2020-09293
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K163312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10432915
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention