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

Model Number 8637-40

Device Problem Volume Accuracy Problem (1675)

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

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2018, (b)(4); an unknown dose and concentration via an implantable infusion pump for non-malignant pain and post lumbar laminectomy syndrome.The patient reported a volume discrepancy.It was reported that the patient did know the volume information.The patient reported they were told the pump needed to be completely empty every 90 days and have new fluid put in.The patient didn¿t believe this was necessary but the healthcare professional (hcp) believed it is necessary.The patient reported that the first time they put in 20cc and removed 17cc so they only used 3cc.The hcp then put a more concentrated fluid "like 5%-10%" and it was a "waste of material only in a month." the patient reported at the end of march the hcp took out the drug and put in less concentrated drug "5%" which worked fine and the patient was not sure what was going on.The patient reported the current setting of the drug worked very well.The patient asked the hcp about the reason for removing the drug and the hcp told them to not worry about it.The patient reported they have an appointment on (b)(6) 2018.The patient reported they have some form of morphine in the pump.No further complications were anticipated/reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.It was reported that the patient did not know they were to get a refill every 90 days when the pump was put in.The patient reported that they had no symptoms.The patient reported that their doctor was the one who was responsible for the volume discrepancy.It was unknown what steps were taken to resolve the discrepancy.The patient reported that the volume discrepancy had been resolved.The patient reported their weight was (b)(6).No further complications were anticipated/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: 7446410
• MDR Text Key: 106801081
• Report Number: 3004209178-2018-08463
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/07/2018
• Date Device Manufactured: 01/18/2018
• 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 Age: 81 YR
• Patient Weight: 87