MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Erythema (1840); Hematoma (1884); Pain (1994); Burning Sensation (2146); Post Operative Wound Infection (2446); Alteration in Body Temperature (4568); Swelling/ Edema (4577)
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Event Date 12/16/2021 |
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 multiple sources (healthcare provider, foreign, clinical study) regarding a patient who was receiving baclofen (750 mcg at 160.11737 mcg/day) via an implantable pump.It was reported that the patient presented with a suspected wound infection.Examination on (b)(6) 2021 revealed redness. clinically, they noted subfebrilitas, rubor, calor, dolor, and subcutaneous fluctuating swelling under the wound.There was no leakage of pus and the wound was still well closed.It was indicated that presumably it was a wound infection and the baclofen pump should be removed, but a subcutaneous haematoma could not be completely ruled out.Biochemical follow-up showed normal wbc, but increased crp (66 mg/l).They punctured the wound fluid for analysis and a culture showed the presence of enterobacter cloacae on (b)(6) 2021. the patient required in-patient or prolonged hospitalization. the entire device system (pump and catheter) were explanted on (b)(6) 2021. regarding outcome, the event resolved without sequelae as of (b)(6) 2021. the devices were disposed of by the healthcare provider according to biohazard instructions. regarding etiology, the relationship of the event to the device or therapy and implant procedure was related. the incisional site/device tract was the pump pocket. the device diagnosis was indicated as being not applicable. the clinical diagnosis was infection of wound. the patient's weight was not measured at baseline.
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Event Description
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Additional information was received from a foreign healthcare provider via a clinical study on 2022-oct-26.The female patient was 53 years old at the time of consent.The pump was implanted on (b)(6) 2021 due to normal battery depletion and it had been explanted without replacement on (b)(6) 2021.
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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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