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

Model Number 8637-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Fever (1858); Headache (1880); Staphylococcus Aureus (2058); Swelling (2091); Visual Disturbances (2140); Discomfort (2330); Meningitis (2389); Post Operative Wound Infection (2446)

Event Date 12/10/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot#: (b)(4), ubd: 05-jun-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a clinical study regarding a patient receiving morphine sulfate 5000 mcg for a total dose of 941.04833 mcg/day via an implantable pump.It was reported on (b)(6) 2019 the patient called stating that they were worried about their pump incision because it was swollen and tender.The patient reported a fever for two days, highest 101 after returning home from hunting.On examination, pump site was slightly swollen, had slight redness, was tender but not warm to touch.It was noted that the incisions were well healed.It was noted the patient was reporting a headache to occipital with radiation to the top of their head and mild photophobia.It was recommended the patient go to the emergency room (er) to be evaluated for fever of unknown origin.The pump site did not appear infected.In the emergency department (ed), viral panel was negative, labs were normal, cxr was normal, blood culture was negative so the patient was sent home.On (b)(6) 2019 the patient was admitted with severe headache and suspected meningitis.Lp was done and cerebrospinal fluid (csf) was cloudy.The patient was positive for staph aureus, was positive for a wound infection, and had bacterial meningitis.On (b)(6) 2019 the patient was admitted and placed on intravenous (iv) antibiotics, rocephin and vanco.The entire system was explanted/not replaced on (b)(6) 2019.The outcome of the event resolved without sequelae on (b)(6) 2020.The clinical diagnosis was bacterial meningitis.The event resulted in life-threatening illness or injury, required in patient or prolonged hospitalization, and resulted in medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to the body structure or body function.The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related.The incisional site/device tract was pump pocket.The event date was (b)(6) 2020.No further complications were reported.

• 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: 9975700
• MDR Text Key: 196590493
• Report Number: 3004209178-2020-07358
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/18/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2020
• Initial Date FDA Received: 04/18/2020
• Date Device Manufactured: 05/29/2019
• 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; Life Threatening; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 178