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

Model Number 8637-40

Device Problems Human-Device Interface Problem (2949); Insufficient Information (3190)

Patient Problems Fall (1848); Pain (1994); Vomiting (2144); Chills (2191); Therapeutic Response, Decreased (2271); Malaise (2359); Sweating (2444); Shaking/Tremors (2515)

Event Date 04/16/2018

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 manufacturer¿s representative (rep) and a patient regarding their implantable drug infusion device.The drugs being delivered were 750 mcg/ml fentanyl at 225.16 mcg/day, 25 mg/ml hydromorphone at 7.505 mg/day, 1,500 mcg/ml clonidine at 450.3 mcg/day, and 15 mg/ml bupivacaine at 4.503 mg/day.The reason for use was spinal pain.It was reported that the patient was feeling cold and having some pain.The issue started on (b)(6) 2018.The patient does not think their pump is working.The rep just read the pump and the logs look fine.The managing healthcare professional (hcp) just did a refill and everything looked fine.The hcp confirmed there to be no issues with the system.The patient did recently start oral meds (movantik) for their constipation and the hcp is thinking this may be the reason why the patient is having symptoms and does not believe it is the pump.Additional information was received on 2018-jul-16.It was reported that the dose of fentanyl was 375.46 mcg/day, hydromorphone was 12.015 mg/day, clonidine was 750.9 mcg/day, and bupivacaine was 8.11 mg/day.Withdrawal symptoms were reported.No interventions were mentioned.The patient stated, "for the past couple of months, when i would give myself a bolus i would get very ill and i would throw up violently, have sweats, have tremors and this made me fall so now i am in the hospital due to a fall".Withdrawals symptoms started "2-3 months ago on and off" (2018) and had a fall on (b)(6) 2018 and is in the hospital due to the fall, as well as his withdrawal symptoms.The patient has not missed any refills.The hospital that he is at has given him oral medication to combat the withdrawal and "i feel fine" since he has been taking the medication.When asked about hearing alarms, the patient stated, "i thought i was, but wasn¿t sure if it was my phone or not.¿ the patient thinks it was the critical alarm that he heard, and says this occurred "a couple months ago about the same time as the withdrawal.¿ the patient was advised that they should consult with the hcp about his withdrawal and fall, and that the hcp should investigate what is causing this issue.The situation is being addressed by the hcp.There were no further complications reported/anticipated.

• 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: 7777652
• MDR Text Key: 116921800
• Report Number: 3004209178-2018-18081
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2018
• Date Device Manufactured: 12/08/2015
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 55 YR