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

Model Number 8637-20

Device Problems Filling Problem (1233); Insufficient Flow or Under Infusion (2182); Device Ingredient or Reagent Problem (2910)

Patient Problems Fatigue (1849); Dizziness (2194); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/01/2021

Event Type  Injury  

Event Description

Information was received from a healthcare provider (hcp) regarding a patient who was receiving morphine (5 mg/ml at.4964 mg/day), bupivacaine (5 mg/ml at.4964 mg/day), and clonidine (400 mcg/ml at 39.72 mcg/day) via an implantable pump for unknown indications for use.It was reported that in (b)(6) 2021 the patient had a refill and there were residual fluid and also some bubbles.The hcp stated that at the end of the aspiration there was a small amount of yellowish fluid. the hcp stated that the pump was then refilled, hours later the patient was seen again because they were concerned about getting overdosed.The hcp reported that they aspirated the pump and there was no volume discrepancy.The hcp stated that the patient had 2 refills following this with no issues.At the patient's last refill on (b)(6) 2022 they noted a small amount of yellow fluid again with no volume discrepancy and filled the pump.8 hours post refill, the patient overdosed and felt dizzy, uncoordinated, dry mouth, and a little sleepy.The hcp stated that the symptoms subsided with no treatment.Of note, the patient had gained weight so it is a little difficult to access.

Manufacturer Narrative

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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14243215
• MDR Text Key: 290378087
• Report Number: 3004209178-2022-05415
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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: 12/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2022
• Date Device Manufactured: 06/21/2018
• 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): Other
• Patient Age: 51 YR
• Patient Sex: Female