MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Pumping Stopped (1503); Battery Problem (2885)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2021 |
Event Type
Injury
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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 via a company representative regarding a patient receiving compounded baclofen 2 00mcg/ml at 991mcg/day, clonidine 200mcg/ml at 99.18mcg/day and bupivacaine 200mcg/ml at 13mg/day via an implantable pump.The patient¿s medical history included ms (multiple sclerosis).It was reported that the patient missed scheduled replacements due to covid and other factors, transportation etc.The patient's pump had a motor stall occur that has not recovered.The pump stalled on (b)(6) 2021.The patient did not have an mri or any other emi/magnetic interactions.The environmental, external or patient factors that may have led or contributed to the issue was the patient was not able to come for scheduled replacement.The diagnostics and troubleshooting performed was log interrogation.Surgical intervention was planned and scheduled for (b)(6) 2021.Additional information was received on (b)(6) 2021 and it was reported that the pump was replaced today, and they added a new pigtail.They were able to aspirate the catheter.
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Manufacturer Narrative
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Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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 physician reported a motor stall on pump with greater 5 months eri (elective replacement indicator).The patient was a high dose baclofen patient.The pump was removed due to the battery depleted.No rotor or dye study was performed.The patient recovered without sequela.
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Manufacturer Narrative
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H3: evaluation of implantable pump serial number (b)(6) revealed residue in the motor gear train and identified wearing on the upper shaft of gear number two.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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