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

Model Number 8637-40

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

Patient Problems Fall (1848); Overdose (1988); Pain (1994); Therapeutic Response, Decreased (2271); Lethargy (2560)

Event Date 02/14/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care provider (hcp) regarding a patient with an implantable drug infusion pump indicated for non-malignant pain.The pump contained hydromorphone (concentration 3 mg/ml, dose 0.4993 mg/day), clonidine (concentration 300 mcg/ml, dose 49.93 mcg/day), and bupivacaine (concentration 30 mg/ml, dose 4.993 mg/day).It was reported the patient was brought into the hospital yesterday ((b)(6) 2017) for overdose symptoms, and a magnet was placed on the pump.The patient had a refill on thursday, and the drug mixture was changed.The hcp did not know what the drug was prior to the refill last thursday.There were reported symptoms of overdose, and the patient being lethargic.The patient had a fall on saturday night ((b)(6) 2017).The hcp was having difficulty completing the programming.The hcp wanted to lower the dose, and a number of tabs were grayed out.The hcp decided to disable patient activated (pa) dosing and was then able to update the pump.The new dose they programmed was hydromorphone at 0.144 mg/day.No further patient complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider via a clinical study on 2018-apr-16.It was reported that patient reported better pain control with hydromorphone than with fentanyl on (b)(6) 2017, and the plan was to rotate the opioid at the next refill as the patient was experiencing decreased therapeutic relief.The pump was refilled on (b)(6) 2017, rotating the opioid from fentanyl to hydromorphone.The patient reported moderate pain and the it rate was increased at this clinic visit.It was noted that the intrathecal (it) rate was programmed to minimal rate while the patient was in the hospital on (b)(6) 2017, and therapy was resumed on (b)(6) 2017.The patient presented to the clinic for a hospital follow-up on (b)(6) 2017 and the pump was reprogrammed.It was noted that the patient was hospitalized at this time.The patient presented to the emergency department on (b)(6) 2017 and was admitted.Clinic notes on (b)(6) 2017 indicated the patient was hospitalized, and hospital staff believed the patient was "over medication from the pump." it was later clarified that the patient was over-medicated.No changes were made to the pump during the hospitalization, but it was noted that the it rate was increased at the clinic visit on (b)(6) 2017.The specific symptoms associated with the hospitalization were not documented.It was noted that the clinical diagnosis was it medication side effects, and the programming date from the most recent refill prior to the event was (b)(6) 2017 at 13:11.The outcome indicated the decreased therapeutic relief was resolved without sequelae on (b)(6) 2017, and the over-medication was resolved without sequelae on (b)(6) 2017.The etiology indicated the event was related to the device/therapy and was not related to the implant procedure.The event was related to the drug (it was specified that hydromorphone was related) and the actions that caused the event was a new drug added and an increased dose.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare professional (hcp) via a clinical study indicated on (b)(6)2017 therapy resumed and the magnet was removed.No further complications were 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: 6429282
• MDR Text Key: 70736301
• Report Number: 3004209178-2017-06255
• 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: health professional,study
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2019
• Date Device Manufactured: 03/30/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 85 YR