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

Model Number 8637-20

Device Problems Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Device Ingredient or Reagent Problem (2910)

Patient Problems Unspecified Infection (1930); No Known Impact Or Consequence To Patient (2692)

Event Date 04/26/2018

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 (hcp) via a manufacturer¿s representative regarding an implantable intrathecal pump intended to deliver saline [1000 ml/ml] at the minimum rate, indicated for intractable spasticity.It was reported that 16cc of fluid were aspirated out of the pump reservoir on (b)(6) 2018 and it appeared yellow and cloudy.Per the caller, 10cc of saline were put in the pump at implant on (b)(6) 2018.It was stated that all the sterile water was aspirated from the reservoir at the time of implant.Per the physician¿s assistant, the patient has a history of infection, but that there were no symptoms of infection.The hcp was sending the fluid to be analyzed.The hcp put drug in to the pump reservoir, but the caller did not know about the type of baclofen with an unknown concentration, along with the pump being left programmed at minimum rate mode.The caller was to confer with the hcp.No further complications were reported.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider on 2018-may-23.It was reported that the cause of the volume discrepancy was unknown, and that there was an unknown device issue.The expected volume was 9.8 cc.The cause of the yellow/cloudy appearance of the aspirated fluid was not determined.Regarding the results of the fluid analysis, it was reported that no bacteria were grown.The patient had no symptoms related to the yellow/cloudy appearance of the aspirated fluid.It was reported that on (b)(6) 2018, the preservative-free saline (yellow/cloudy) was removed, they flushed the reservoir with saline, then filled with the baclofen prescription without incident.It was reported that the issues were resolved.No further complications were reported or anticipated.Additional information was received from a business partner on 2018-may-24.The patient¿s medical history included spastic diplegic cerebral palsy and infection.The patient¿s concomitant medications included ms contin (morphine sulfate), tramadol (tramadol hydro chloride), baclofen, promethazine (promethazine hydrochloride) and trazodone (trazodone hydrochloride).Reference regulatory report #3007566237-2018-01665 for the manufacturer's report regarding the infection related to the patient's first pump in (b)(6) 2017.

• 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: 7537996
• MDR Text Key: 109047246
• Report Number: 3004209178-2018-11667
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2018
• Date Device Manufactured: 03/13/2018
• 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: 43 YR
• Patient Weight: 107