MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Device Alarm System (1012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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Information was received from a healthcare provider regarding a patient who was receiving baclofen (unknown) (unk mcg/ml at unk mcg/day) via an implantable pump for unknown indications for use.It was reported that the healthcare provider (hcp) stated the patient¿s pump started alarming.There was no further information.The technical services (tss) provided information for nas and caller stated she will have physician call.Additional information was received from a healthcare provider (hcp) indicated that the healthcare provider (hcp) reached out and stated that the pump has not been interrogated yet, so the alarm has not been confirmed.They reached to review guidelines on pressure, altitude, and airport security guidelines.The company representative (rep) was informed of the incident.The alarm was heard last weekend.Additional information received from a health care provider (hcp) indicated that the patient's weight was unknown at the time of the event.When asked to clarify the pump alarming, the hcp stated that it turned out that the pump was not actually alarming, per logs taken one week later.It was indicated that the device was still in use.
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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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