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

Model Number 8637-40

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Headache (1880); High Blood Pressure/ Hypertension (1908); Muscle Weakness (1967); Nausea (1970); Pain (1994); Anxiety (2328); Discomfort (2330); Depression (2361); Sleep Dysfunction (2517); Fluid Discharge (2686); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)

Event Date 10/23/2020

Event Type  Injury  

Event Description

Information was received from a consumer regarding a patient receiving morphine and bupivacaine via an implanted infusion pump.It was reported the patient's pump was out of medications on (b)(6) 2020.The patient was unable to see their hcp to have the pump refilled, and they could feel they were now going through medication withdrawals.The patient had pain in their back, occasional muscle spasms and generally feeling anxious.The patient was provided clonidine and was planned to follow-up in 1 to 2 days.Later in the day the patient felt their pain was severe, had nausea, restless legs, and could not get comfortable.The patient was going to be prescribed oral morphine.The patient was discharged in the am the next day.On (b)(6) 2020, the patient was unable to aspirate csf from the catheter.The patient had a leak with their morphine pump so they used a dye to see where it was leaking.A leak was located consistent with a catheter fracture and the hcp planned to do surgery tomorrow.The patient had been empty meaning the patient had not had any morphine in a few days.After the patient left the office they began to have nausea, vomiting and ill.It was noted the vomiting was likely due to an allergic reaction from the contrast dye.The patient was reevaluated and the nausea had greatly improved and the patient had not had any subsequent vomiting.Later that night, the patient continued to have nausea, patient was given the option to stay for a liter of fluids and a repeat dose of zofran and patient agreed.Afterwards, the patient was feeling much better.The patient's pain was 8/10 and was described as stabbing and aching.It was noted sitting increased their pain and ice decreased the pain.The patient didn't want an increase.The patient had tenderness in the lumbar spine, left paraspinal and right paraspinal.On (b)(6) 2020, the patient's pain was a 8/10.The patient the nausea had started to subside.The patient had headaches and pain in their groin.An it pump refill kit was ordered for the patient.On (b)(6) 2020, the patient pump and catheter were replaced.It was noted 3 days later the patient was seen and noted there was oozing coming from the stitches.The patient had nausea/vomiting, hypertension, and couldn't keep anything down.Zofran had not been helpful.On (b)(6) 2020, the patient went to the clinic with no opioids withdrawal complaints since the new it pump implanted.The two incisions had no signs of infection.The patient had been vomiting and had not been able to take their oral pain meds.The patient's pain level was a 7/10 today and they were feeling tired.There were no complications from the pump revision.The patient presented to the pain management clinic for a 2 week follow after a pain pump replacement procedure.The patient stated that they were getting 70% relief and rates their pain at a 6/10.The patient was requesting an increase in their pain pump today.The patient had no vomiting and the incisions staples were removed.On (b)(6) 2020, the patient presented to the pain management clinic for increased pain all of their body.Patient stated that everything hurts and that nothing is helpful in decreasing their pain except laying down helps some.The patient rated their pain at an 8/10 today.The patient also was feeling tired, sleep disturbances, anxiety, depression and muscle weakness.No need for it pain pump adjustment today.

Manufacturer Narrative

Concomitant medical products: product id: 8709, serial# (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2020, product type: catheter.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 30-mar-2012, udi#: (b)(4).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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12909340
• MDR Text Key: 283607204
• Report Number: 3004209178-2021-17842
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/01/2021

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: 02/28/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 12/01/2021
• Date Device Manufactured: 08/30/2016
• 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): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 81 KG