MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Pumping Stopped (1503); Insufficient Information (3190)
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Patient Problem
Pain (1994)
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Event Type
Injury
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Event Description
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Information was received from a consumer regarding a patient receiving an unknown drug via an implantable pump.The indication for use was non-malignant pain.The patient reported their pain pump was no longer working and the patient was in pain.Per the patient, their healthcare provider was ordering a new one 2 weeks ago and when the patient called today, they had nothing.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from the consumer indicated that last friday the healthcare provider turned down the medication to the lowest level pending surgery to replace the pump due to motor stall.It was noted around the end of (b)(6) 2022, the pump started stalling and kept stalling.The patient was hearing the single toned alarm and it was alarming every hour due to the low reservoir.The dosing was set to the lowest level and put the patient was put on oral medication.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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