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

Model Number 8637-40

Device Problems Migration or Expulsion of Device (1395); Unstable (1667)

Patient Problems Stroke/CVA (1770); High Blood Pressure/ Hypertension (1908); Pain (1994); Swelling (2091); Loss of Vision (2139); Therapeutic Response, Decreased (2271); Weight Changes (2607)

Event Type  Injury  

Manufacturer Narrative

Continuation of medical devices: product id 8780, serial# (b)(4), implanted: (b)(6) 2017, product type catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2018, information was received from a patient receiving morphine (unknown concentration, 5 mg/day) via an implantable pump for non-malignant pain.The patient reported they were having problems with the pump in (b)(6) 2018 and their healthcare professional (hcp) was going to do a test on (b)(6) 2018.The patient had been bed ridden and their hcp was saying they had "spine rot".The patient stated they had disc disease and stenosis.The patient was wondering if their weight was pinching the "little tube".The patient weighed (b)(6).The patient had lost 125 lbs.And was trying to lose more.The pump was working for the patient and they "became a new person".About 2 months ago, the patient "suddenly" kept asking for more morphine which the hcp "gladly put in".The patient used to take 60 mg of morphine by mouth.The patient was in pain now, which began in (b)(6).The patient stated they were in the hospital for 8 days (specific dates were not reported).The patient had a spike in their blood pressure and "they thought she stroked out".The patient stated their brain swelled and they went completely blind.The patient then stated there was no correlation between the hospital stay and the pump.The patient had to have mris performed and asked if they could damage the pump.Tech services reviewed mri guidelines and the patient stated their pump did restart.The patient stated the pain started after the hospital stay.On (b)(6) 2018, the patient called back and reported they saw their hcp yesterday ((b)(6) 2018) because their pump was not working.The patient stated that their blood pressure going up was because of the pump.Yesterday, they determined the pump was flipped.The patient had lost 120 lbs.And had "extra skin".The patient stated that the hcp drained all the morphine out of the pump and flipped it in the office.

Manufacturer Narrative

Due to imdrf harmonization, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2018, additional information was received from the patient.The patient reported they were told that the pump had flipped do to weight loss.The patient was also told to stay at the same body weight in the future.

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: 7648913
• MDR Text Key: 112694068
• Report Number: 3004209178-2018-14622
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

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: 02/14/2019
• 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: 06/05/2018
• Initial Date FDA Received: 06/28/2018
• Supplement Dates Manufacturer Received: 07/16/2018; 08/08/2018
• Supplement Dates FDA Received: 07/24/2018; 10/04/2018
• Date Device Manufactured: 08/18/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 84