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

Model Number 8637-40

Device Problems Inadequacy of Device Shape and/or Size (1583); Insufficient Flow or Under Infusion (2182)

Patient Problems Itching Sensation (1943); Nausea (1970); Rash (2033); Sepsis (2067); Urinary Retention (2119); Vomiting (2144); Malaise (2359); Sleep Dysfunction (2517); Weight Changes (2607); Constipation (3274); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient receiving intrathecal unknown morphine previously (concentration and dose unknown) via an implanted pump for non-malignant pain.It was reported the patient had a blood infection for over a year and had been on steroids for over 45 years which was causing her body to fracture and had a fractured pelvis and was going through morphine withdrawals.It was further reported her pump was empty and she had been going through morphine withdrawal for 86 days.The patient had the pain pump implanted due to rheumatoid arthritis very bad.It was noted "the same doctor got me addicted, he gave me 245 norco and 175 xanax (then said 250 norco and 175 xanax) for decades and i was addicted, i very much fell down and was addicted, and i had surgery on my feet and they gave me percocet".It was reported the patient had a blood infection and fractured pelvis and was going through morphine withdrawal and was very sick.The patient inquired if that was normal.The patient asked if they should put her in the hospital to wean her off this (the pump)? it was reported the doctor ¿ghosted me¿.Physician listings were offered, and the patient refused stating "i need to know how much longer i am going to have to suffer with this pump, because last time they did a reading on it was (b)(6) 2021 and they were saying ¿i don't have any more, and my alarm was still going off¿.It was reported the patient was so sick, ¿i almost had a heart attack¿.It was noted the patient was vomiting and going to the bathroom at the same time.The patient lost 40 pounds and needed someone to help.It was reported the patient was reading from the book the "potential adverse effects in clinical studies".The patient reported the following symptoms from "the book", " you are "irathical" morphine, nausea, vomiting, constipation, urinary retention, ¿i have all that.I don't have daytime drowsiness, i am itchy, i have a rash, i am not sleepy, i am wide awake, i cant sleep." it was noted the reason for the call was the patient wanted to report her physician.The patient demanded to speak to a supervisor because "i can die from this, understand".The patient was redirected to their healthcare provider to further address the issue.Additional information was received from a consumer on 2022-feb-04 indicated she had been vomiting/throwing up.It was reported she had cancer and congestive heart failure and that she "just fell on my right knee." the patient also complained about the size of her pump stating that "it is so big it was laying on my intestines.¿.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13636053
• MDR Text Key: 288652817
• Report Number: 3004209178-2022-02641
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2022
• Date Device Manufactured: 03/27/2018
• 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): Other
• Patient Sex: Female