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

Model Number 8637-40

Device Problems Filling Problem (1233); Device Ingredient or Reagent Problem (2910); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8596sc; serial#: (b)(4); implanted: (b)(6) 2015; explanted: (b)(6) 2022; product type: catheter.Other relevant device(s) are: product id: 8596sc, serial/lot #: (b)(4), ubd: 24-sep-2017, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care professional (hcp) regarding a patient receiving bupivacaine (30 mg/ml at unknown dose), prialt (18.7 mcg/ml at unknown dose) and baclofen (2250 mcg/ml at unknown dose) via an implantable infusion pump.It was reported that during a refill, the hcp expected 1.6ml but aspirated 8ml.The patient noted that was fairly typical for his re fills.During this refill, the hcp also stated he was getting a lot of backpressure after filling the pump with about 25ml of medication.Then when he aspirates, he gets air but little to no drug.He tried aspirating multiple times but gets the same result.He switched refill kits and got the same result.The caller was in the patient's home and could not perform any troubleshooting steps.No further complications were reported.Additional information was received from the hcp that the cause of the backpressure was not determined.The patient was seen on (b)(6) 2021 and aspiration did not bring back any residual volume.The hcp injected contrast into the pump and it was visualized under fluoroscopy in the reservoir.Aspiration was done and they were able to aspirate the contrast plus the residual volume.The issue was reported to be resolved at the time of this report.Additional information received from a healthcare provider (hcp) reported that the patient had a recent pump and catheter replacement.The hcp stated that the catheter was replaced due to precipitate in the catheter, which was first seen in the pump on (b)(6) 2021 and at refills the pump was rinsed each time.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14240773
• MDR Text Key: 290466624
• Report Number: 3004209178-2022-05405
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2022
• Date Device Manufactured: 10/01/2015
• 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: 46 YR
• Patient Sex: Male