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Model Number 8637-40 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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Information was received from a healthcare provider regarding a patient who was receiving an unknown drug via an implantable pump for non-malignant pain and chronic low back pain.It was reported that the healthcare provider (hcp) asked about magnetic resonance imaging (mri) labeling.They stated that the patient had a "fractured" or "fragmented" lead; technical services asked if hcp was referring to the catheter and they were unsure but stated that the patient only had the pump implanted and no other implanted devices.Hcp also mentioned that pump had been empty and had been beeping for years (reported in pe (b)(4)).Technical services reviewed typical pump longevity and that it would makes sense for the pump to alarm due to end of service.Reviewed option for patient to have the alarm silenced or have the pump explanted.Hcp stated that the mri was needed "to get the pump out" and that the patient had a "foreign body script." .
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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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Search Alerts/Recalls
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