Model Number 13827 |
Device Problems
Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)
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Patient Problems
Pocket Erosion (2013); Patient Problem/Medical Problem (2688)
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Event Date 04/09/2020 |
Event Type
Injury
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Manufacturer Narrative
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Pending follow-up from reporter, including specific device information.(b)(4).
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Event Description
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Received voluntary medwatch 5094218 from fda.Health professional reported a prometra ii pump that may be explanted due to alleged erosion.Report states, "patient was implanted with prometra ii flowonix pump 2017.The pump was placed in the left rear flank and was in approved location.The pump was refilled multiple times until noticed in 2020 that there was an erosion directly above the protruding nipple of the refill port.Unlike other devices on the market (mdt synchromed ii) the refill port is elevated above the plane of the device.This produces contact on the overlying dermal layers and could cause this failure.Now, due to covid-19, we are reluctant to go to hospital to replace or remove.Managing with oral antibiotics and reducing dose.".
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Event Description
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Received voluntary medwatch 5094218 from fda.Health professional reported a prometra ii pump that may be explanted due to alleged erosion.Report states, "patient was implanted with prometra ii flowonix pump 2017.The pump was placed in the left rear flank and was in approved location.The pump was refilled multiple times until noticed in 2020 that there was an erosion directly above the protruding nipple of the refill port.Unlike other devices on the market (mdt synchromed ii) the refill port is elevated above the plane of the device.This produces contact on the overlying dermal layers and could cause this failure.Now, due to covd-19, we are reluctant to go to hospital to replace or remove.Managing with oral antibiotics and reducing dose." per follow-up, physician reported that patient is also being treated with wound care.Physician opted to turn off the pump at this time.
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Manufacturer Narrative
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Additional data: serial #, lot #, expiration date, udi #).Corrected data: (model #, catalog #).Performed dhr review which includes verification of all steps in the manufacturing of the pump, verification of all final testing performed by/on the pump, verification of sterilization, and packaging for subject pump was performed.The review did not identify any non-conformances, issues or capas associated with pump function.Per follow-up with physician, patient has a "sedentary lifestyle." requested contact from physician if/when explant surgery occurs.Internal complaint # - (b)(4).
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Event Description
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Received voluntary medwatch 5094218 from fda.Health professional reported a prometra ii pump that may be explanted due to alleged erosion.Report states, "patient was implanted with prometra ii flowonix pump 2017.The pump was placed in the left rear flank and was in approved location.The pump was refilled multiple times until noticed in 2020 that there was an erosion directly above the protruding nipple of the refill port.Unlike other devices on the market (mdt synchromed ii) the refill port is elevated above the plane of the device.This produces contact on the overlying dermal layers and could cause this failure.Now, due to covd-19, we are reluctant to go to hospital to replace or remove.Managing with oral antibiotics and reducing dose." per follow-up, physician reported that patient was also being treated with wound care.Physician opted to turn off the pump and then explanted the pump.Physician additionally reported a "disconnect at the pump stem." per the physician, the disconnect, "let the medication in the pump blow by the catheter and dribble into the pocket.".
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Manufacturer Narrative
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Device was unable to be analyzed as it was discarded.The alleged disconnection at the pump stem could not be confirmed as the pump was not returned for analysis.There was no further information provided and potential root cause for the erosion could not be determined.Per instructions for use, 'pump site skin erosion' is included as one of the 'possible risks associated with programmable implantable pump'.If additional information is received, a supplemental report will be submitted.Internal complaint # (b)(4).
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Search Alerts/Recalls
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