MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Pumping Stopped (1503); 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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Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.Interrogation of the pump upon receipt indicated that the pump was delivering baclofen (2,000.0 mcg/ml at 1,204.5 mcg/day).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 regarding a patient receiving baclofen at 1200 mcg/day via an implanted pump.The indication for pump use was cerebral palsy and intractable spasticity.It was reported that the patient¿s pump was alarming every 10 minutes.It was the critical alarm.Per the reporter, the pump had been filled recently and they confirmed that the pump reservoir volume had been updated accordingly.The hcp could not interrogate the pump until monday.The patient was taking oral baclofen and was not experiencing symptoms.Additional information was received from a company representative who reported that the pump was replaced due to a motor stall.
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Manufacturer Narrative
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H3: the pump was returned and destructive analysis identified residue in the motor gear train.Analysis 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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