MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/15/2022 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2019.Product id: 8780, serial/lot #: (b)(4), ubd: 06-aug-2021, udi#: (b)(4).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 multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving an unknown drug via an implantable pump for non-malignant pain.It was reported that the patient failed a catheter dye study and decided to have the pump removed since she was also driving 3 hours to have it refilled.Surgery was scheduled for (b)(6) 2022. the issue was not resolved at the time of this report. the patient's medical history included chronic pain. the patient was reported alive with no injury at the time of this report.
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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 received reported that the cause for the failed dye study was not determined.The device was explanted so the issue was resolved.
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Search Alerts/Recalls
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