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); Aspiration Issue (2883)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 01/05/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer representative on (b)(6) 2018 regarding a patient receiving unknown medication (dose and concentration unknown) via an implanted infusion pump.The indication for use was spinal pain.It was reported that during a typical refill on (b)(6) 2018, the hcp expected to collect 4ml of fluid and collected 12ml.A dye study was ordered, however, the patient was allergic to intravenous pyelogram (ivp).The environmental, external, or patient factors that may have led or contributed to the issue were unknown, and it was unknown if any other diagnostics or troubleshooting were performed.Actions/interventions taken to resolve the issue were unknown, but it was noted that surgical intervention was planned.No intervention had been scheduled at the time of report, and the issue was considered unresolved.The patient's status at the time of report was alive; no injury, and no further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative on (b)(6) 2018.It was reported that the dye study had not been scheduled yet.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer representative (rep) via the healthcare professional (hcp) and patient.The patient was receiving fentanyl 6700 mcg/ml, 1300 mcg/day.It was reported that the patient had increased pain since (b)(6) 2017.The patient underwent a pocket revision but no change to the catheter in (b)(7) 2018.The patient had more medicine in the pump than what was expected on (b)(6) 2018; the hcp was expecting 4.6 ml and received 11 ml back.There were no known environmental, external or patient factors that may have led or contributed to the issue.A dye study was performed on (b)(6) 2018 and the hcp was unable to aspirate the catheter.Surgical intervention was planned; the hcp wrote an order on (b)(6) 2018 for the patient to have a catheter revision, turned the pump to minimum rate and substituted with oral medication.The issue was not resolved and the patient status was "alive - no injury" at the time of this report.No further complications were reported.

Manufacturer Narrative

Product id 8780 lot# (b)(4) implanted: (b)(6)2015 explanted: b)(6)2018 product type catheter product id 8780 lot# (b)(4) ubd: (b)(4)2016-, udi#: (b)(4) implanted: (b)(6)2015 explanted: (b)(6)2018 product type catheter if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a company representative.The device was returned to the manufacturer last week.As per the manufacturer¿s device registry, the catheter was explanted and replaced on (b)(6)2018.

Manufacturer Narrative

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 from the manufacturer representative via return paperwork.The catheter was clogged.No further complications were reported.

Manufacturer Narrative

The catheter was returned, and analysis found a tear in the seal near the guide ring of the sutureless catheter connector.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: 7172393
• MDR Text Key: 96663162
• Report Number: 3004209178-2018-00390
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/04/2018

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: 09/28/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/11/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2018
• Initial Date FDA Received: 01/08/2018
• Supplement Dates Manufacturer Received: 01/08/2018; 02/12/2018; 04/03/2018; 03/18/2018; 05/22/2018
• Supplement Dates FDA Received: 01/09/2018; 02/15/2018; 04/04/2018; 04/16/2018; 06/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 44 YR