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

Model Number 8637-40

Device Problems Failure To Service (1563); Volume Accuracy Problem (1675); Device Displays Incorrect Message (2591); Human-Device Interface Problem (2949)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Discomfort (2330); Lethargy (2560)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer and a healthcare provider (hcp) regarding a patient receiving bupivacaine(11.8 mg/ml, 2.6 mg/day) and dilaudid(10 mg/ml.2.2 mg/day) via an implantable infusion pump for the treatment of non-malignant pain and failed back surgery syndrome.It was reported by the consumer that the pump was alarming or beeping.They were concerned because the alarm had been going off for days.At first, they thought it was the refrigerator since the alarm was so quiet.The alarm was going off every 10 minutes.The patient had no medication left in the pump.The refill date was in march but the clinic did not call them to make an appointment like they usually did.The patient missed a refill.The patient's whole body hurt starting (b)(6) 2018.The hcp told him to take zelbrex because his knees and everything were hurting so bad.He had tried oxycodone but her husband could not handle that because it would knock him out.The patient's wife went to pick up some hydrocodone and that was fine.The patient started hearing the alarm probably a week ago.The patient met with on-call hcp at the clinic on (b)(6) 2018 and she was going to change the pump so that it would deliver the least amount of medication.It was reported that the patient's pump was empty.When the hcp accessed the pump on (b)(6) 2018, they were able to pull out 2 ml and filled the pump with 10 ml of normal saline.They planned to have the patient back on (b)(6) 2018.The provider prescribed some oral medication and a narco to manage any withdrawal symptoms.The patient was "feeling kinda achy and lethargic" over the weekend.The event date was noted as (b)(6) 2018.Additional information was received on 2018-apr-10 from the hcp.The patient went to the clinic on (b)(6) 2018 for a refill of drug.A bridge bolus was programmed on (b)(6) 2018 and was to infuse for 52 hours at a rate of 1.4 mg/day.20 hours had elapsed and they were going to refill the patient's pump.The patient was going to a center to have the cap aspirated post refill.No further complication was reported.

Manufacturer Narrative

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: 7426039
• MDR Text Key: 105774298
• Report Number: 3004209178-2018-07902
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/09/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 04/24/2018
• Supplement Dates FDA Received: 04/24/2018
• Date Device Manufactured: 09/15/2014
• 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 Age: 55 YR