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

Model Number 8637-20

Device Problem Pumping Stopped (1503)

Patient Problems Muscle Spasm(s) (1966); Muscular Rigidity (1968); Pain (1994); Therapeutic Response, Decreased (2271); Sleep Dysfunction (2517)

Event Date 06/30/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a foreign healthcare provider (hcp) via a manufacturer representative on 2020-jul-09 regarding a patient receiving unknown medication (dose and concentration unknown) via an implanted infusion pump.It was reported that the pump did not work and the patient experienced symptom return.A rotor test was done and the pump could not turn as expected.The pump was replaced by a new one and the issue was considered resolved at the time of report.There were no environmental, external, or patient factors that may have led or contributed to the issue.The patient's status at the time of report was alive - no injury and no further complications were reported or anticipated.

Manufacturer Narrative

H3: the returned device was subjected to a series of standard tests that include but is not limited to visual inspection, alarm output, motor function, and dispense testing.The returned device passed all testing in the laboratory and no anomalies were identified.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.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Pump interrogation at medtronic european operations center indicated the pump was delivering baclofen 2000,0 mcg/ml at 399,7 mcg/day.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.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

H3: analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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.

Event Description

Additional information was received from a foreign hcp via a user report that was forwarded to the manufacturer by a foreign regulatory agency on 2020-aug-07.It was reported that the date of the event was on (b)(6) 2020 (the previous report indicated the event date was on (b)(6) 2020).The user report noted that the intrathecal baclofen pump was used for treatment of spasticity, specifically spastic tetra paresis in cerebral palsy.The pump had to be explanted on (b)(6) 2020 due to a "pump malfunction table" that resulted in severe baclofen withdrawal syndrome and an exacerbation of the patient's spasticity, including permanent contractures with spasms of the extremities especially in the lower limbs, appearance of diffuse muscle pain, and secondary insomnia.The patient's symptoms began on (b)(6) 2020 and the patient was reportedly hospitalized on (b)(6) 2020, and then transferred to functional neurosurgery on (b)(6) 2020 for specialized care.Oral substitution of baclofen and clinical surveillance were also done.A test was done on that day in the radiology department, which "made evoke a failure of the pump because the catheter was well permeable." the pump was replaced and it was noted that the hcp decided not to change the catheter because it was in place, in good condition, and working properly.Per the user report, by the evening of the same day, they could already see the beneficial effects of the new pump, with the disappearance of all signs of weaning and clear improvement of the patient's spasticity.The next day, after a slight increase in the dose of baclofen, the patient's spasticity was good and the patient was able to return home.It was indicated that confirmation of a technical failure of the pump after two years of being implanted was done by three elements: the clinic presented by the patient, the test of the pump's functioning and control that evoked its failure, and the patient's marked improvement after the pump change while leaving the intrathecal catheter in place.

• 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 00777
• MDR Report Key: 10267019
• MDR Text Key: 198627668
• Report Number: 3004209178-2020-12069
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 21 YR