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

Model Number 8637-20

Device Problem Volume Accuracy Problem (1675)

Patient Problems Therapeutic Response, Decreased (2271); Underdose (2542)

Event Date 04/16/2018

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 provider (hcp) via a manufacturer's representative regarding a patient who was receiving compounded baclofen (unknown concentration and dose) via an implantable pump for an unknown indication for use.It was reported that on (b)(6) 2018, the volume reported by the n'vision was less than the volume aspirated.The patient experienced underdose symptoms and a small reduction in the effect of therapy.The hcp was still studying this volume difference and had requested the presence of medtronic at the next refill that would occur approximately 15 days from (b)(6) 2018.Actions taken were continued study by medical staff and medtronic, as reported.It was reported there were no contributing factors to the event.The pump remained implanted and in service.The issue was not resolved.The patient status was alive - no injury.No medical or surgical intervention was needed, the event did not lead to or extend hospitalization, and there was no injury as a result of this event.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.Apparently there was no problem with the patency of the catheter.The pump rotor had normal operation.They were trying to identify the cause of the volume discrepancy.The last refill was carried out on (b)(4) 2018.The pump did not show any difference of aspirated volume and informed volume.They would follow at the next two refills.No actions were taken, they just performed the refill according to manufacturer guidelines.They would follow the next steps in order to ensure that everything happens well.

Manufacturer Narrative

Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturer representative indicated the residual volumes at the (b)(6) 2018 refilled included an expected reservoir volume (erv) of 11,9ml and an actual reservoir volume (arv) of 11,18ml.The representative confirmed that the reported volumes were correct.

• 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: 7499159
• MDR Text Key: 107753687
• Report Number: 3004209178-2018-10457
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2018
• Date Device Manufactured: 10/12/2016
• 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