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

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Erythema (1840); Rash (2033)

Event Date 05/23/2019

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 professional (hcp) via a company representative regarding a patient receiving morphine (20 mg/ml at 1.99 mg/day) via an implanted pump.The indication for pump use was non-malignant pain.On (b)(6) 2019 it was reported that the patient was admitted to the hospital on (b)(6) 2019 after being seen in the er (emergency room) with a rash and redness.The patient was diagnosed with a p.Aeruginosa (pseudomonas aeruginosa) infection.On (b)(6) 2019, the surgeon removed the pump, did a ¿wash procedure¿, and then placed it back in the patient.On (b)(6) 2019, the patient contacted their pump managing physician¿s office and wanted to have their pump interrogated to make sure it was still on.The pump was interrogated on (b)(6) 2019; it was still delivering the prescribed dosing; and remained in service.It was noted that the managing physician may increase the patient¿s dose after they are out of the hospital and well.He wanted to wait to change the dosing until after the patient was out of the hospital.The issue was not resolved at the time of this report.The patient was still being managed in the hospital for the infection.It was indicated that the hcps had no further information to provide regarding the event.The patient status was reported as ¿alive ¿ with injury¿ with the injury noted as ¿currently has p.Aeruginosa infection which is being managed in the hospital via pic line¿.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 received reported that the patient was moved to a rehab facility.The pump was interrogated on (b)(6) 2019 showing normal functioning.A dye study was scheduled for (b)(6) 2019.No further complications were reported regarding the event.

• 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: 8663166
• MDR Text Key: 146812808
• Report Number: 3004209178-2019-10707
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2020
• 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: 06/19/2019
• Date Device Manufactured: 01/03/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 82