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

Model Number 8637-20

Device Problems Premature Elective Replacement Indicator (1483); Human-Device Interface Problem (2949); Insufficient Information (3190)

Patient Problems Anxiety (2328); Distress (2329)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8840, serial #: (b)(4), product type: programmer, physician.Other relevant device(s) are: product id: 8840, serial/lot #: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer and a healthcare professional (hcp) regarding a patient receiving fentanyl (300.0 units/ml at 118.39 units/day) and morphine (40.0 mg/ml at 15.785 mg/day) via an implanted pump.The indication for pump use was not reported.On (b)(6) 2019 it was reported that the critical alarm was sounding on the patient¿s pump.Per the patient, her hcp (healthcare professional) didn¿t tell her until the end of (b)(6) 2018 that she needed her pump replaced, so she didn¿t get any info about the replacement surgery that¿s scheduled for (b)(6) 2019 until recently.She had an anxiety attack when she was told that the pump would need to be replaced.The printout she had said her pump was supposed to quit working on (b)(6) 2019, so it needed to be replaced before that date.The patient stated that she was concerned because she didn¿t want to go without medication and risk withdrawal and return of pain from (b)(6) 2019 when the pump stopped to (b)(6) 2019 when the pump was going to be replaced.The pump was recently refilled on (b)(6) 2019.At that time, the hcp ¿wasn¿t able to recalibrate the pump because the pump was at eri (elective replacement indicator)¿.The hcp told her the eri message meant ¿hey, this pump is dying and needs to be replaced¿ and ¿due to the eri the pump wasn¿t allowing the hcp to recalibrate the pump so that the pump could reflect that it had been refilled and show that the pump was actually dispensing medication¿.Per the patient, some women in the office (who worked for the hcp) came in and pressed buttons (on the clinician programmer) and told the patient this info and the doctor said to them ¿wait a minute then the patient won¿t get the full dosage¿.The pump was critically alarming while the patient was in the doctor¿s office and the doctor was aware of this.The pump had been alarming since ¿probably last month¿.At first the pump was sounding a single alarm and now it was sounding the critical alarm every 15 minutes.The patient didn¿t mind the alarm, she was just concerned and didn¿t want the pump to stop delivering medication before she could get it replaced with a new pump.It was explained to the patient that once the pump reached eos (end of service) it would sound the critical alarm and then stop delivering medication.The patient was upset by this because she was under the impression from what she was told by her hcp that even though the pump was alarming the pump was still delivering medication.Additional information was received on (b)(6) 2019 from an hcp who reported that at the pump refill on (b)(6) 2019 it wouldn¿t allow them to reprogram the pump after the refill.The only option was to stop the pump.The cause for the programming difficulty was not determined.The pump was refilled and they left programming, etc.As was previously.Pump replacement was still planned for (b)(6) 2019.No further complications have been reported as a result of this event.

Manufacturer Narrative

Product id: 8870, product type: software.Section 'device' information references the main component of the system.Other relevant device(s) are: product id: 8870.If information is provided in the future, a supplemental report will be issued.

• 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: 8325425
• MDR Text Key: 135707775
• Report Number: 3004209178-2019-02819
• 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,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2019
• Date Device Manufactured: 03/24/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 59