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

Model Number 8637-40

Device Problems Occlusion Within Device (1423); Unstable (1667); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 05/07/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional via manufacturer representative regarding a patient who was receiving an unknown drug at an unknown concentration and dose via intrathecal drug delivery pump for non-malignant pain.It was reported that during a refill on (b)(6) 2018, the patient had a high residual volume of 37 ml aspirated from the pump.The patient had poor pain relief.There were no known environmental, external or patient factors that may have led or contributed to the issue.No diagnostics or troubleshooting were performed, and no interventions were taken to resolve the issue.Surgical intervention did not occur and it was unknown whether it was planned.The issue was not resolved and the patient status was "alive - no injury" at the time of this report.No further complications were reported.Additional information was received from the healthcare professional via manufacturer representative.It was reported that the expected residual volume at refill was 2 ml.Surgical intervention was not planned.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 the healthcare professional via manufacturer representative.It was reported that the old catheter was twisted and kinked at the spinal site.The distal end was left in-situ and tied off, and the remaining catheter was removed.The pump was flipped in the pocket and the sutures were broken.The old pump was removed.A new pump and catheter were implanted.No alarms were noted.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 the healthcare professional via manufacturer representative.It was reported that the product was not returned; the customer sent it to pathology per hospital protocol and did not request analysis.No further complications were reported.

• 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: 7511255
• MDR Text Key: 108644126
• Report Number: 3004209178-2018-10817
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2018
• Initial Date FDA Received: 05/14/2018
• Supplement Dates Manufacturer Received: 05/18/2018; 06/13/2018
• Supplement Dates FDA Received: 06/06/2018; 06/14/2018
• Date Device Manufactured: 04/08/2017
• 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): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 120