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

Model Number 8637-40

Device Problems Failure To Service (1563); Device Displays Incorrect Message (2591); Human-Device Interface Problem (2949); Material Integrity Problem (2978)

Patient Problems Therapeutic Response, Decreased (2271); Sleep Dysfunction (2517)

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8598, serial#: (b)(4), implanted: (b)(6) 2005, product type: catheter.Product id: 8709, serial#: (b)(4), implanted: (b)(6) 2005, product type: catheter.Product id: 8598, serial/lot #: (b)(4), ubd: 28-mar-2007, udi#: (b)(4).Product id: 8709, serial/lot #: (b)(4), ubd: 28-nov-2006, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer (con) regarding a patient receiving 25 mg/ml morphine, 1 mg/ml dilaudid and 250 mcg/ml clonidine all of an unknown daily dose via an implantable infusion pump for non-malignant pain.It was reported that on (b)(6) 2018, the pump was alarming for 3 days before it was supposed to alarm and the patient was going through withdrawal.The patient asked to know if she was still going through withdrawal because she slept for 15 hours since (b)(6) 2018.The patient reported thinking there was a problem with the pump as it was alarming before the refill.The patient was provided with breakthrough medication when the healthcare professional (hcp) released her on (b)(6) 2018 because the patient missed an appointment.When the patient saw the hcp on (b)(6) 2018 the hcp started her programming from square one like in 2001m reduced programming from 18 milligrams to 2 milligrams.On (b)(6) 2018 the patient had l5, l4 surgery and her nerves were a mangled mess and the hcp realized the catheter was in the way and cut the catheter and grafted it and sewed it back up together and the patient was hearing a lot of beeping while in the hospital.The patient stated she heard a lot of beeps while in the hospital but she was not sure if the pump was alarming when the hcp cut the catheter.No further complications were expected or anticipated.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7556536
• MDR Text Key: 109902734
• Report Number: 3004209178-2018-12200
• Device Sequence Number: 1
• Product Code: LKK
• 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
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2013
• 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: 05/29/2018
• Date Device Manufactured: 11/14/2011
• 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: 60 YR