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

Model Number 8637-20

Device Problem Application Program Problem (2880)

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

Event Date 02/19/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8840, serial# (b)(4), product type: programmer, physician.Product id: 8870aar01, serial# (b)(4), product type: software.Information references the main component of the system.Other relevant device(s) are: product id: 8840, serial/lot #: (b)(4), ubd: , udi#: (b)(4); product id: 8870aar01, serial/lot #: (b)(4), ubd: , udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional via a company representative regarding a patient receiving baclofen (600 mcg/ml at 73.53 mcg/day) and morphine (8 mg/ml at 0.9803 mg/day) via an implanted pump.The indication for pump use was non-malignant pain and post lumbar laminectomy syndrome.It was reported that when the patient came in for a refill on (b)(6) 2018, the pump was interrogated and it showed the low and empty reservoir alarms occurred, however, there was still 4.6 ml left with 15.6 ml dispensed.The logs from the refill on (b)(6) 2018 were reviewed and showed that the pump was changed at 16:27 and then changed again at 16:29 after which the empty and low reservoir alarms logged.No logs were printed which captured the change made.It was noted that the 8840 clinician programmer they were using had an (b)(6) software card which was not the current software card version.They were not sure if this was the 8840 clinician programmer used for the last refill on (b)(6) 2018 as well or if they had been using this 8840 clinician programmer for other patient¿s too since they were a large account with many 8840 clinician programmers.No patient symptoms were reported.There were no complications.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare professional who reported that it was unknown what programming change was made between the 16:27 and 16:29 timeframe on (b)(6)2018.No further complications were reported/anticipated.

• 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: 7624764
• MDR Text Key: 111890323
• Report Number: 3004209178-2018-13962
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2017
• 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: 06/28/2018
• Date Device Manufactured: 10/05/2015
• 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: 54 YR
• Patient Weight: 118