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

Model Number 8637-20

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

Patient Problems Fever (1858); Unspecified Infection (1930)

Event Date 12/13/2019

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 consumer regarding a patient receiving hydromorphone (1000 mcg/ml at unknown dose), clonidine (100 mcg/ml at unknown dose), droperidol (20 mg/ml at unknown dose) and baclofen (100 mcg/ml at unknown dose) via an implantable infusion pump.The indication for use was noted to be non-malignant pain.It was reported that the patient went in for a refill on (b)(6) 2019 but she "had a temperature" and they were worried she had an infection so "they gave me pills" and put the refill off until (b)(6) 2019.The patient noted it was "probably just a cold, not an infection" but the hcp had given her a small bag of antibiotics just in case.The patient had a refill on the 26th and when trying to give a bolus on the 27th her myptm application stated that boluses were disabled.The patient was redirected back to her hcp to address the bolus issue.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 from a health care provider on 2020-jan-16.It was reported that there was "no infection, only uri." it was further reported that there was no programming error in regards to the bolus disabled message.The boluses had been added to her continuous infusion to see how that rate would handle her pain.There was just a misunderstanding between the hcp and the patient.No interventions were taken besides explaining the issue to the patient.The issue was considered resolved and the patient's weight was unknown.No further complications were reported.

• 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: 9531319
• MDR Text Key: 182586341
• Report Number: 3004209178-2019-24542
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2020
• Date Device Manufactured: 08/17/2017
• 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): Other
• Patient Age: 64 YR