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Model Number NEU_LABEL_ACC |
Device Problem
Labelling, Instructions for Use or Training Problem (1318)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/07/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a healthcare professional regarding a patient who was implanted with a neurostimulator for spinal cord stimulation - non-malignant pain/ chronic low back pain.It was reported that the healthcare provider (hcp) called back in reference to the mri guidelines she was sent.Caller stated the patient's model number was not listed in the mri guideline document.Patient services reviewed that the quick reference guide is missing this model number to do an oversight.Caller was directed to the appropriate location in the document that listed the model as mri conditional.No symptoms reported.No further complications were reported/anticipated.
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Search Alerts/Recalls
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