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

Model Number 8637-20

Device Problems Insufficient Flow or Under Infusion (2182); Application Program Problem (2880)

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

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id 37092, product type accessory.Product id neu_ptm_prog.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was receiving 2500 mcg/ml of fentanyl at 549.9 mcg/day via an implantable pump for non-malignant pain.On (b)(6) 2020, it was reported that the patient's pump was always locking them out when they tried to deliver a bolus.According to the patient, they would always see a 3 hour lockout.The patient provided their personal therapy management programmer (ptm) lockout parameters as: 1x/3h, 8x/day.It was considered possible that the patient was experiencing uplink interference.The patient's healthcare provider (hcp) reportedly did not know why the lockouts were happening.The patient was sent a ptm antenna.The patient also reported that they did not believe that they were getting all their boluses because there was always drug left in the pump at refills.The patient reported have 10 ccs or more in the pump and the hcp was varying refill dates from 6 to 8 weeks sometimes because there was drug in the pump.The patient noted that they sometimes do not use all of all 8 boluses.No symptoms were reported.No further complications were reported.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10444651
• MDR Text Key: 204524926
• Report Number: 3004209178-2020-14633
• 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
• Type of Report: Initial
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 08/24/2020
• Date Device Manufactured: 04/09/2015
• 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