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

Model Number 8637-40

Device Problems Filling Problem (1233); Volume Accuracy Problem (1675); Suction Problem (2170); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2017

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 healthcare professional (hcp) via a manufacturer¿s representative regarding a patient who was receiving lioresal at an unknown concentration and dose via an implantable pump for intractable spasticity.It was reported on (b)(6) 2017 that at the pump refill on (b)(6) 2017 the hcp refilled the pump and noted the expected residual volume (erv) was 5.1 ml and 7 ml were actually aspirated.There were no known environmental/external/patient factors that may have led or contributed to the issue.No diagnostics or troubleshooting was performed no interventions/actions were taken to resolve the issue.It was unknown if the issue was resolved at the time of the report.No surgical intervention occurred and no surgical intervention was planned.The patient status at the time of the report was ¿alive ¿ no injury.¿ it was indicated that the representative would send pertinent information when obtained on 2017-mar-01.The patient medical history included cerebral palsy (cp) and spasticity.The patient weight was asked but unknown.Other medications the patient was taking at the time of the event could not be obtained as they were not available to the manufacturer.Additional information was received from the representative on 2017-mar-06.It was reported that the representative did not yet obtain any new information.It was indicated that there were no known symptoms that the patient experienced related to the volume discrepancy observed on (b)(6) 2017.It was again indicated that there were no known troubleshooting or diagnostic testing performed.It was reported that the cause of the volume discrepancy was unknown.The pump refill was performed on (b)(6) 2017.Further information was received from the representative on 2017-mar-20.It was reported that the hcp didn¿t leave the correct printout and to the representative¿s knowledge the patient was doing well.No further complications were reported or anticipated.Additional information was reported by a healthcare provider (hcp) indicated that the patient was receiving lioresal (2000 mcg/ml) at an unknown dose reported to be "a little more than 1600 mcg/day" via an implantable infusion pump.It was reported that there has always been some sort of slight volume discrepancy with the patient's pump.During the patient's most recent refill appointment the actual reservoir volume was calculated to be 10.1 ml and the expected reservoir volume was 7.3 ml.It was noted that on a refill appointment on (b)(6) 2018 the arv was 6.8 ml and the erv was 4.2 ml.It was reported that the patient was experiencing autonomic storming.The refill accuracy chart was sent to the hcp.The caller stated that she would bring the patient back earlier to check for volume discrepancy and check the logs as well.No further complications have been reported as a result of this event.Additional information was received from a healthcare provider (hcp) and a device manufacturer representative indicated that the patient was having withdrawal symptoms.It was reported that the patient had been experiencing these symptoms for two months and had been provided medications for the symptoms.The pump logs were read dating back to (b)(6) 2018 and no anomalies were found.The caller stated that a catheter dye study and a rotor study were performed and everything was functioning properly.It was reported that the patient symptoms may be related to the patient's gastrointestinal issues (gi); the patient had a feeding tube and it was distending in the abdomen.It was reported that once they extended the gi tube that the patient became less agitated.The hcp was directed to keep a diary of the feeding tube and any agitation to see if there was something abnormal there.No further complications have been reported as a result of this event.

Manufacturer Narrative

(b)(4) was included in the previous report by error.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7694733
• MDR Text Key: 114211025
• Report Number: 3004209178-2018-15933
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 11/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 YR