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

Model Number 8637-20

Device Problems Excess Flow or Over-Infusion (1311); Application Program Problem (2880)

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

Event Date 08/16/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8835, serial#: unknown, product type: programmer.Other relevant device(s) are: product id: 8835, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was receiving an unknown drug via an implantable infusion pump for chronic low back pain and spinal pain.The patient reported a physician bolus in progress (8503) code on their personal therapy manager (ptm).It was reported that the pump was recently refilled.The patient reported the time left on the physician bolus was 27 hours.The patient reported they understood the 8503 code and that issue was resolved.However, it was reported that they got a successful bolus after the refill.The patient reported that they had check with the ptm after and saw a lockout of 3hr 50min, waited that amount of time, and was able to deliver a bolus around 7pm.The patient reported that after that the ptm showed the 8503 code.No symptoms were reported.No further complications were anticipated/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: 7870443
• MDR Text Key: 122190298
• Report Number: 3004209178-2018-20490
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2018
• Date Device Manufactured: 07/04/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1570-2014
• Patient Sequence Number: 1
• Patient Age: 70 YR