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

Model Number 8637-20

Device Problem Disconnection (1171)

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

Event Date 12/28/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, serial#: (b)(4), implanted: (b)(6) 2012, product type: catheter.Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: 24-may-2014, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care professional (hcp) via a device manufacturer representative regarding a patient receiving morphine (40 mg/ml at 13.998 mg/day) and clonidine (1400 mcg/ml at 489.6 mcg/day) via an implantable infusion pump.The indication for use was noted to be non-malignant pain.It was reported that during a normal and expected pump replacement for battery depletion it was determined that the catheter was not connected to the pump.The surgery was on (b)(6) 2018.There were no patient symptoms reported and no issues noted prior to the surgery.The cause of the event was undetermined.The catheter was securely attached to the new pump.The issue was considered resolved.The patient's weight was provided.The patient's status at the time of the report was alive - no injury.No further complications were reported.

• 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: 8206580
• MDR Text Key: 131782539
• Report Number: 3004209178-2018-28516
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00613994779229
• UDI-Public: 00613994779229
• 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
• Report Date: 12/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2013
• 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: 12/28/2018
• Date Device Manufactured: 03/02/2012
• 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: 64 YR
• Patient Weight: 41