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

Model Number 8637-20

Device Problems Occlusion Within Device (1423); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Material Integrity Problem (2978)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)

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 provider via a company representative regarding a patient receiving an unknown drug via an implantable pump.The indication for use was non-malignant pain.It was reported that the actual and residual volumes were not matching closely enough at pump refill.Per the reporter the physician was withdrawing too much drug from the pump at refill.The patient¿s pain was increasing.The physician was planning a pump replacement.The environmental, external or patient factors that may have led or contributed to the issue was noted as ¿n/a¿.It was unknown if any diagnostics or troubleshooting performed.Or actions and interventions taken to resolve the issue.The issue was not resolved at the time of the report.The patient status was noted as alive, no injury and no further complications were reported.

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, serial#: (b)(4), implanted: (b)(6) 2010, product type: catheter.The main component of the system.Other relevant device(s) are : product id: 8709sc, serial/lot#: (b)(4), ubd: 25-may-2012, udi#: (b)(4).¿analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.¿ if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received that reported the reason for the catheter removal was break, tear, hole, and questionable occlusion.The patient had loss of therapy.The patient recovered without sequela.The indication for use was also post lumber laminectomy.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 on 06-feb-2018 from a healthcare professional via a company representative who reported that the physician suspected a pump issue.As of 06-feb-2018, the pump had not been explanted yet.No further complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received on (b)(4) 2018 from the manufacturer¿s representative (rep).The drugs being delivered were 15 m g/ml hydromorphone at 5 mg/day, 150 mcg/ml clonidine at 50 mcg/day, 500 mcg/ml droperidol at 166.67 mcg/day, and 15 mg/ml morphine (unknown) at 5 mg/day.It was reported that the actual reservoir volume (arv) was greater than the expected reservoir volume (erv).The volumes from the most recent refills were provided.On (b)(4) 2017, the erv was 3.1 and the arv was 6.5.On (b)(4) 2017, the erv was 10 and the arv was 10.9.On (b)(4) 2017, the erv was 6.3 and the arv was 13.On (b)(4) 2018, the erv was 8 and the arv was 13.Troubleshooting considerations were suggested, including to consider doing a dye study and to consider a revision.Logs show no indication of a motor stall or pump problem.The rep stated that the healthcare professional (hcp) was considering a pump replacement, and the rep was advised to have the hcp consider a catheter revision/replacement as well if they go that route.There were no further complications reported/anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

A portion of the catheter was returned in 3 segments.Analysis of the catheter segments returned found ¿catheter body ¿ broken¿ and ¿catheter sc connector ¿ coring/tears/cuts in seal¿.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

(b)(4).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: 7243453
• MDR Text Key: 99077423
• Report Number: 3004209178-2018-02122
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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,Followup,Followup
• Report Date: 04/23/2018

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: 08/28/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2018
• Initial Date FDA Received: 02/06/2018
• Supplement Dates Manufacturer Received: 02/06/2018; 02/07/2018; 03/12/2018; 03/12/2018; 04/23/2018; 04/23/2018
• Supplement Dates FDA Received: 02/07/2018; 02/08/2018; 03/12/2018; 03/12/2018; 04/23/2018; 04/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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