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

Model Number 8637-40

Device Problems No Audible Alarm (1019); Pumping Stopped (1503); Intermittent Infusion (2341)

Patient Problems Therapeutic Response, Decreased (2271); Obstruction/Occlusion (2422); Shaking/Tremors (2515); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/27/2018

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 manufacturer representative and a consumer regarding a patient receiving unknown baclofen 4000mcg/ml for a unknown total dose via an implantable pump for intractable spasticity and head/brain injury.It was reported the pump has been in and out of motor stalls since approximately (b)(6) 2018.It has recovered each time until the last time when it stayed stalled since (b)(6) 2018.There was no magnetic resonance imaging (mris) in the patient's record.Factors that may have contributed or led to the event was noted as not applicable.Diagnostics/troubleshooting included the pump was interrogated to confirm motor stalls.Actions/interventions included the patient was being sent for replacement.It was noted that no surgical intervention occurred, but surgical intervention was planned but not yet scheduled.The issue was not resolved at time of report.The patient's weight and medical history was asked, and will not be made available.The patient's status at time of report was alive- no injury.It was later reported the patient was currently in hospital.It was noted that yesterday ((b)(6) 2018) a "tech" came to check the patient's pump, which had stopped on the (b)(6).It was noted the patient was waiting to be transferred to another hospital to have their pump taken out/replaced.It was stated that the patient has had a change in symptoms since the (b)(6) around (b)(6) stating the patient was having "cold turkey withdrawals" and was tremoring, shaking, and had bowel obstruction.The patient was hospitalized the day after (b)(6) due to symptoms.The patient's mom was upset with their patient's healthcare professional (hcp) as they dismissed the caller's concerns referring patient to primary care physician (pcp) for symptoms.The patient was currently in the hospital for return of symptoms.A tech came yesterday ((b)(6) 2018) to the hospital and read the pump.The pump reading determined the patient's pump had been stalling for a while and "may have been some of the things we were seeing initially." it was determined the patient's pump stopped on (b)(6) 2018.It was noted that he patient's pump was to be replaced later this year.The patient's mother asked if there was another hcp in the area.Listings of hcps were emailed.The patient's mother asked to speak with the tech who read the patient's pump yesterday ((b)(6) 2018).Reps in the area were emailed.It was noted that the patient was on the highest dose.The patient's pump was to be replaced soon.The event date was (b)(6) 2018 ((b)(6)).No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer's representative (rep).It was reported that a nurse first reported the incident.It was reported the patient was still waiting on a transfer to the appropriate hospital to have the pump replaced.The issue had not been resolved.No further complications were anticipated/reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp).The patient was transferred from an outside facility to another hospital with severe baclofen withdrawal.When the pump was interrogated, it was in a motor stall for six days before the patient was transferred.The pump was explanted two days after the patient was admitted to the hospital.No further issues 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.

Event Description

Additional information was received from the consumer.It was reported when the pump malfunctioned by stopping it never alarmed.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• MDR Report Key: 7649236
• MDR Text Key: 112693229
• Report Number: 3004209178-2018-14629
• 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,consum
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0497-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 28 YR