MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Use of Device Problem (1670); Application Program Problem (2880); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: neu_unknown_prog, serial#: unknown, product type: programmer, physician.Other relevant device(s) are: product id: neu_unknown_prog, serial/lot #: unknown.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) regarding a patient who was receiving baclofen (unknown) (2000 mcg/ml at 424 mcg/day) via an implantable pump for unknown indications for use.It was reported that the hcp stated that the patient missed a refill due to covid and a scheduling conflict. it was stated that the patient and their spouse are hard of hearing and cannot hear the alarm. it was noted when the hcp interrogated the pump today ((b)(6) 2020) the empty reservoir alarm occurred on (b)(6) 2020. it was stated that the actual residual volume was 1.5ml and the patient was having no therapy issues. it was discussed to refill the pump and no priming was needed. the hcp inquired about aspirating from the catheter access port (cap) to rule out an occlusion. it was reviewed it was a medical decision. it was noted that troubleshooting resolved the reported issue.No symptoms were reported.No further complications were reported/anticipated.
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Event Description
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Additional information received from a healthcare professional (hcp) reported it was confirmed that an empty reservoir alarm occurred.The software version of the clinician programmer was provided.Actions/interventions included refill procedure.It was noted they were able to aspirate 1.5ml at refill procedure.The cause of the volume discrepancy was determined.The cause was noted as mistaken alarm date and scheduled incorrectly.It was noted that the issue was resolved.The patient's weight was 180 pounds noted on 2019-feb-11.It was noted they don't routinely weigh patients.No further complications were reported.
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Manufacturer Narrative
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Continuation of d10: product id a810, serial# unknown, product type: software.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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