MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problem
Electromagnetic Interference (1194)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/16/2024 |
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 recieved from a company representative regarding a patient receiving intrathecal bupivacaine 20 mg/ml at 2.48 mg/day and morphine (unknown) 10 mg/ml at 1.2 mg/day via in implantable pump for spinal pain indications.The patient had an magnetic resonance imaging (mri) in july and had since had several refills, however, they had all been done using the 8840 programmer.However, when physician interrogated the patient and then the company rep interrogated patient today, service code 529 for motor stall and recovery appeared.Technical services confirmed that was the first time the patient's pump had been interrogated with the new software version 2.0 and motor stall/recovery was only at the time in july.
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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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Additional information received from a health care provider (hcp) via a manufacturer representative (rep) provided the name and address of the hcp who initially reported the event to the rep.
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Search Alerts/Recalls
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