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 12/12/2023 |
Event Type
malfunction
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Event Description
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Information was received from multiple sources (manufacturer representative, healthcare provider (hcp)) regarding a patient who was receiving intrathecal unknown baclofen (concentration and dose unknown) via an implantable pump for intractable spasticity.It was reported that the hcp interrogated this patient's pump for the first time after an mri and it showed the pump was still stalled.Technical services reviewed telemetry mode.The rep would discuss with the hcp.
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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 was recieved from the company representative (rep) indicating that the physician reported issue to them.It was also noted that the device was in telemetry mode and volume confirmed pump continued to work.There were no symptoms of underdose.The time of the motor stall recovery was unknown and they had no further info.The patient's weight was asked, but made unknown.
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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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