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

Model Number 8637-40

Device Problems Particulates (1451); Device Ingredient or Reagent Problem (2910)

Patient Problem Purulent Discharge (1812)

Event Date 04/15/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider via a company representative regarding a patient receiving compounded baclofen 750 mcg/ml at 420 mcg/day via an implantable pump.On (b)(6) 2020 the healthcare provider reported that he pulled ¿pus¿ from the patients pump reservoir.The healthcare provider stated it looked greenish and had stringy solid like particles in it.The patient was asymptomatic but has a hernia in the area of the pump.The provider said he pulled out 6.1 ml of the ¿pus¿ like fluid when 6.8ml was expected.He then did 2 saline flushes and removed what he put in, confirming in his mind that he was in the reservoir.The healthcare provider put in new baclofen medication and monitored the patient for 30 minutes and the patient remained asymptomatic.He reports the first flush still had the stringy particles in it but the second flush was clear.The provider did not save the ¿pus¿ fluid for analysis.The environmental, external or patient factors that may have led or contributed to the issue was the patient had a hernia near pump pocket that has not been treated because of covid-19 pandemic.The diagnostics and troubles shooting performed was 2 saline flushes to clean the reservoir.There were no actions and interventions taken to resolve the issue.It was unknown if the issue was resolved at the time of the report and it was noted that the healthcare provider would not have any further information regarding the event.The patient status was noted as alive, no injury and no further complications 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: 9976484
• MDR Text Key: 192367466
• Report Number: 3004209178-2020-07363
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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
• Report Date: 04/20/2020

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: 06/14/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2020
• Initial Date FDA Received: 04/20/2020
• Date Device Manufactured: 12/27/2016
• 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 Age: 49 YR