Model Number DM3500 |
Device Problems
Overheating of Device (1437); Appropriate Term/Code Not Available (3191)
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Patient Problems
Pain (1994); Discomfort (2330); Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Medwatch form user facility report# : (b)(4) dated feb, 2019.(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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It was reported that the patient presented for an mri scan.The patient reported they had an implanted loop recorder device.The device was checked against the manufactures recommendations for safe mri procedure by the facility.The device was noted to be conditionally safe.The conditions included using 1.5 tesla field and implant not being placed within six weeks of the mri.The field was 1.5 t but the implant had been placed 37 days prior, short of the six week recommendation.The patient reported heating and a sharp pain in the area of the loop recorder.The mri was stopped.The patient was to return to a clinic for further assessment.No additional information is available at this time.
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Event Description
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New information received notes the implantable cardiac monitor was working and still implanted in the patient.The patient was fine.
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Search Alerts/Recalls
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