MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Itching Sensation (1943); Muscular Rigidity (1968); No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 10/16/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving baclofen 2000 mcg/ml at a dose of 600 mcg/day via an implantable infusion pump.It was reported that the patient had experienced symptoms of underdose with the pump and that the pump had less residual volume than specified in the pump data.The pump was emptied and refilled, and fluoroscopy with contrast agent was done.The patient was also given oral supplemental medication and was monitored.Additional information later received stated that none of the symptoms of underdosing reported by the patient could be detected by the doctors at any time during the hospital stay.The fluoroscopy with contrast medium revealed complete patency of the catheter.It was reported that a psychologist was consulted who found out that the patient had problems in their private life and therefore made false statements in order to get attention.No further complications were reported or anticipated.

Manufacturer Narrative

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.

Manufacturer Narrative

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.

Event Description

Additional information was received from a foreign healthcare professional (hcp) via a manufacturer representative.It was reported that no volume discrepancies occurred during the refill on (b)(6) 2020 or any other subsequent pump fillings.

Manufacturer Narrative

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.

Event Description

Additional information was received from the treating doctor in response to a request for follow-up on 2020-(b)(6).It was reported that this doctor took over the patient on 2020-(b)(6) for paraplegiological complication treatment.Immediate clinical and paraplegiological examinations with diagnostic imaging were initially carried out.Clinically, the patient presented himself in a significantly reduced general condition with spasticity that emphasized the abdomen.At all times the patient was three-fold oriented and complained mainly of a pruritus, which had spread from the head to the trunk.A covid-19 smear was taken, which turned out to be negative.In addition, diagnostic imaging showed no evidence of catheter malfunction, tear or disconnection.The calculated administration of diazepam 10 mg as required and also the oral baclofen administration with 25 mg per os every 3 hours.The vital signs showed a normotonic pulse of 93 / min and a rr 140/90 mmhg.The oxygen saturation was 98 percent.Pain was not reported.The immediate readout of the drug pump upon admission did not indicate a malfunction and the parameters remained unchanged.The reservoir volume was given as 13 ml.The pump reservoir was punctured under highly sterile conditions under the control of an image converter.With a problem-free puncture, 2 ml instead of 13 ml could be aspirated.Due to the discrepancy in the reservoir values, the reservoir was punctured again after a few minutes, but no further medication/fluid could be aspirated.Immediately afterwards the pump was refilled with a total of 6.5 ml of baclofen.The side port was then punctured.Before the puncture, an existing pinhead-sized hematoma was noticed in this area.The side port could be punctured without problems and clear liquid could be aspirated without problems.The course of the catheter was shown using a contrast medium (imeron 300).A normal contrast medium flow from the catheter tip intrathecally was found without any indication of stenosis or granuloma/obstruction, and a leak could not be detected in the course of the catheter.The pump was then reprogrammed with bolus delivery, which correspondedto the volume of the catheter tube.A flush bolus was triggered over a period of 15 minutes.There were multiple consultations with the customer service of the drug pump manufacturer.After the transmission of the available data and the epicrisis, no indication of a malfunction of the pump could be detected.On the same day the mri with contrast medium was performed to rule out pathologies of the spinal cord and other infections of the spine.This showed an unchanged material position with dorsal stabilization in bwk [thoracic vertebrae] 5-8 with known screw breakage of both screws in bwk 8 since 2013.No signs of loosening could be identified.The spine was properly configured.The patient was clearly symptom-free under the inpatient therapy.There were no spasticity or vegetative accompanying symptoms of pruritus, hypertension, tachycardia or priapism could be determined in the inpatient course.A regular reading of the drug pump also showed no indication of a drug pump malfunction.It was also noted that the patient was experiencing chronic and very pronounced coprostasis, for which treatment was initiated.As of 2020-(b)(6), the patient had no spasticity, no "withdrawal symptoms", abundantly discharged during the night.The pump was read out, working properly, with the next pump alarm: 2020-(b)(6).The pump eri (elective replacement indicator) was 69 months.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• MDR Report Key: 10834096
• MDR Text Key: 222941587
• Report Number: 2182207-2020-01269
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2021
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 79