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

Model Number 8637-40

Device Problem Failure To Service (1563)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was provided by a healthcare provider via a manufacturer¿s representative regarding an implantable intrathecal pump intended to deliver morphine at a concentration of ¿1¿ at a dose of ¿1¿ and "none," indicated for non-malignant pain.It was reported that the patient moved to (b)(6) and couldn¿t find someone to fill pumps.The event date was reported as (b)(6) 2016.Factors that may have led or contributed to the issue included they were unable to fill the pump and found cbd (cannabidiol) oil working.It was indicated that as part of diagnostics/troubleshooting, the checked with several doctors to fill the pump and were unable.They called multiple places as an intervention/action taken to resolve the issue.It was indicated that the issue was resolved.It was reported that surgical intervention occurred, and the pump was explanted on (b)(6) 2018.The patient¿s status was unknown.No further complications were reported or anticipated.The patient¿s medical history and weight were asked but unknown.Other medications the patient was taking at the time of the event could not be obtained as they were not available to the manufacturer.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare provider via a manufacturer's representative on (b)(6) 2018.The patient's status was reported as "alive - no injury." it was indicated that the device would not be returned, as it was kept by the account.It was stated that there was no issue with the device.The provided information was confirmed with the physician/account.No further complications were reported or anticipated.

• 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: 7569626
• MDR Text Key: 110092534
• Report Number: 3004209178-2018-12600
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2015
• 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: 06/05/2018
• Date Device Manufactured: 05/12/2014
• 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: 59 YR