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Model Number 8637 |
Device Problems
Electromagnetic Interference (1194); Battery Problem (2885)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Information was received from a healthcare provider regarding a patient receiving an unknown drug via an implantable pump.The indications for use was unknown.It was reported that the caller, a healthcare provider, requested pump to be turned off for a patient having surgery unrelated to the pump, as they stated it was their policy to do so.The manufacturer's technical services specialist (tss) reviewed the manufacturer did not have a recommendation to turn off the pump.The caller stated they were told they had to turn it off because in the past they had a pump where the battery was "fried" due to cautery.The caller did not know when it occurred or have any patient info but was able to provide the physician's name.
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Search Alerts/Recalls
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