MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-02-28 for MAGNETOM SKYRA 10432915 manufactured by Siemens Healthcare Gmbh- Mr.
[188483472]
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.
Patient Sequence No: 1, Text Type: N, H10
[188483473]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808157-2020-09293 |
| MDR Report Key | 9770291 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-17 |
| Date of Event | 2019-11-12 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-02-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MEREDITH ADAMS |
| Manufacturer Street | 40 LIBERTY BLVD. 65-1A |
| Manufacturer City | MALVERN, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 4486461 |
| Manufacturer G1 | SIEMENS HEALTHCARE GMBH- MR |
| Manufacturer Street | HENKESTRASSE 127 |
| Manufacturer City | ERLANGEN, GERMANY 91052 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 91052 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAGNETOM SKYRA |
| Generic Name | SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING |
| Product Code | LNH |
| Date Received | 2020-02-28 |
| Model Number | 10432915 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE GMBH- MR |
| Manufacturer Address | HENKESTRASSE 127 ERLANGEN, GERMANY 91052 GM 91052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-02-28 |