MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Failure to Interrogate (1332); Communication or Transmission Problem (2896); Inappropriate or Unexpected Reset (2959)
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Patient Problem
Paresthesia (4421)
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Event Date 01/10/2024 |
Event Type
Injury
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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 a healthcare provider (hcp) via a company representative (rep) regarding a patient who was receiving fentanyl via an implantable pump.The indication use was for non-malignant pain.The healthcare provider (hcp) reported that the patient was able to use their personal therapy manager (ptm) last night but today she was not able to get it to find/connect to the pump at all.The caller stated that there was zero progress when the patient tried to find the pump.It would instantly go to no pump found message.They stated that she tried two different communicators and there was no progress either on the pump interrogation.It was noted that they were getting consistently no pump found.The hcp performed an ultrasound and confirmed the pump was not flipped and the pump was very superficial, and she can feel the port.The technical service (ts) tried reading the pump with the invision programmer and telemetry failed immediately also zero progress on the pump interrogation screen.The caller confirmed the patient has not had any falls or trauma to the area.The patient reported a sensation of pins and needles all over her body.The ts reviewed that there were no other troubleshooting suggestions.Additional information was received from a healthcare provider (hcp) stated that they were unable to interrogate the pump.The practice nurse used portable ultrasound machine to determine if pump had flipped upside down but it was right side up.It was noted that there was no critical alarm.
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Event Description
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Additional information was received from a company representative (rep) and healthcare provider (hcp) reporting that the patient's weight at the time of the event was 93 kg.It was reported that the pump was replaced to resolve the telemetry issues/pump not found.The new pump was implanted and successfully reprogrammed.The issue was resolved.
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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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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 from a health care provider (hcp) via a manufacturer representative (rep) indicated that the cause unable to connect to pump was not determined and the pump would be returned.Per pump logs, it showed that a critical alarm-pump reset due to low battery occurred on (b)(6) 2024 at 4:46 am and 4:47 am.
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