MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Insufficient Flow or Under Infusion (2182); Improper Flow or Infusion (2954)
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Patient Problems
Ambulation Difficulties (2544); Swelling/ Edema (4577)
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Event Date 03/01/2021 |
Event Type
malfunction
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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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Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving lioresal (2000 mcg/ml at 1780 mcg/day) via an implanted pump.The indication for pump use was multiple sclerosis and intractable spasticity.It was reported that at refills they had been getting volume discrepancies that were 14-17% off going back to (b)(6).The patient¿s condition had not changed, but the patient was complaining that she could not get up and walk and she had edema.
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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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Event Description
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Additional information was received from a healthcare provider (hcp) via the company representative who reported that the expected residual volume at the visit was 4.6 ml and the actual residual volume was 7.0 ml.The date of the visit was not provided.The volume filled and volume programmed at the refill prior to the visit was 19 ml.The cause of the volume discrepancies was unknown.With regarding to any actions/interventions that were or would be taken to resolve the issue, it was noted that a dye study was recommended.At the time of the report, the devices were still in use.
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Search Alerts/Recalls
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