(b)(4).This initial mdr will be the only report submitted for mfr report #3008114965-2018-00759.Additional patient and event information has been requested; however, a response has not yet been received.Additional initial reporter information has been requested; however, a response has not yet been received.Additional information will be provided within 30 days of receipt.
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Product complaint # (b)(4).This final mdr will be the only report submitted for mfr report #3008114965-2018-00759.Additional information received on october 22, 2018: the patient experienced a minimal increase in pain, but was very attentive.The patient's pain was reported to be a 6 on the visual analog scale (vas) of pain, otherwise a 3.T he pump was implanted on (b)(6) 2013.The patient's last refill procedure was on (b)(6) 2018.Morphine was being administered through the pump at 1.4mg/24h.No side effect were experienced.A procedural delay of less than 30 minutes was reported.Conclusion: based on the information, the event could not be confirmed.The product was not returned for analysis; however a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.It was noted that the physician missed the patient¿s pump refill date.The pump alarmed when it was low.The device is working as intended.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.
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