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

Model Number 8637-40

Device Problem Volume Accuracy Problem (1675)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id 8780, serial# (b)(4), implanted: (b)(6) 2015, product type catheter, udi# (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer and a healthcare provider (hcp) via a manufacturer representative regarding a patient who was receiving morphine 27 mg/ ml; 18.011 mg /day via an implantable pump.Indication for use was spinal pain.The date of the event was (b)(6) 2018.It was reported the pump had increasing reservoir volume remaining at refills.At the last refill 2 ml remained in the pump and the hcp withdrew 6 mls.The patient experienced withdrawal symptoms occasionally at night.There were no environmental/external/patient factors that may have led or contributed to the issue.A dye and rotor study were conducted.No interventions were taken after the dye and rotor study.The pump and catheter were patent per the hcp.Surgical intervention did not occur and was not planned.The issue was resolved.Patient status was alive - no injury.Patient weight and medical history were asked but were unknown.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 healthcare professional (hcp) via a manufacturer representative.The date of the event was approximately (b)(6) 2017.The patient first started experiencing withdrawal (b)(6) 2017.The actual residual volume (arv) and expected residual volume (erv) were only known from the last fill in (b)(6) 2018.The arv was 5-6 ml and the erv was 2.7 ml.The cause of the volume discrepancy was not determined.A rotor and dye study were completed, and nothing was found.

• 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: 7510443
• MDR Text Key: 108241407
• Report Number: 3004209178-2018-10785
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2018
• Date Device Manufactured: 05/07/2015
• 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 Age: 67 YR