MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Pumping Stopped (1503); Application Program Problem (2880); Inappropriate or Unexpected Reset (2959)
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Patient Problems
Itching Sensation (1943); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/22/2022 |
Event Type
malfunction
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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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Information was received from multiple sources (friend/family member, healthcare provider) regarding a patient who was receiving morphine, baclofen and fentanyl via an implantable pump for intractable spasticity.It was reported that the patient went to the emergency room with symptoms (in bad shape and itchy) and was not treated because the idea was that there was an issue with the pump.Additional information was received indicated that the critical alarm was activated.The handset indicated alert code 114; pump stopped- reset occurred.When the pump was interrogated it was in minimum rate and the elective replacement indicator had changed to 2029 ; the caller was able to set the pump out of minimum rate and into simple continuous.The device was able to be reprogrammed but then alarmed again due to the patient using an external pemf device that they place over their abdominal wall again which resulted in a safe state mode.They were able to silence the active alarm and update the pump with no issues.The patient was asked to stop using the pemf device as it could be causing the pump safe state.
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Event Description
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Additional information received from the healthcare provider reported that the patient's expected elective replacement indicator (eri) is (b)(6) 2026 based on calculations.
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Manufacturer Narrative
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Continuation of d10: product id a810 lot# serial# unknown implanted: explanted: 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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