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

Model Number 8637-20

Device Problem Contamination (1120)

Patient Problem Meningitis (2389)

Event Date 12/11/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter. If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional via manufacturer representative (if applicable) regarding a patient who was receiving infumorph (10. 0 mg/ml, 1. 0 mg/day) via intrathecal drug delivery pump for non-malignant pain. It was reported that the catheter and pump were implanted normally on (b)(6) 2017 and an infection (fungal meningitis) and contaminated implant was suspected. Labs were being run and would take 5-7 days. The pump and catheter were planned to be explanted on (b)(6) 2017. The issue was not resolved and the patient status was unknown at the time of this report. It was unknown whether the pump and catheter would be returned to the manufacturer. 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 the healthcare professional via manufacturer representative (rep). It was reported that the patient was hospitalized awaiting explantations of the pump and catheter and was being treated for infection. Explant had occurred and the devices were sent to the lab. The rep had requested both pump and catheter be given to him for return. The lab results were: negative for bacterial infection; testing for fungal had not been completed and would take 10-14 days. The cause of fungal meningitis/contamination was undetermined. 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: 7112980
• MDR Text Key: 94695585
• Report Number: 3004209178-2017-25909
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/13/2017 Patient Sequence Number: 1