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 Low Blood Pressure/ Hypotension (1914); Complaint, Ill-Defined (2331); Sedation (2368)

Event Date 05/06/2017

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 received from a healthcare provider via a manufacturer representative regarding a patient receiving dilaudid 1 mg/ml at 0.15 mg/day via an implanted pump for non-malignant pain and failed back surgery syndrome.The patient was implanted with their pump system on (b)(6) 2017.On (b)(6) 2017, the patient had symptoms of being sedated, low blood pressure and respiratory problems.The patient had two fentanyl 50 mcg patches on their body when they arrived into the emergency room two days after implant.The pump was interrogated, it was confirmed the dose was as ordered at implant (dilaudid 1 mg/ml at 0.15 mg/day).The dose was decreased by (b)(4) by the physician to dilaudid 1 mg/ml at 0.1 mg/day.The patient's fentanyl patches were removed.The patient was intubated, blood pressures controlled and was transferred to intensive care unit (icu) for monitoring.No surgical intervention occurred or was planned.It was later reported on (b)(6) 2017 that it appeared there was a miscommunication regarding other pain medications the patient was taking and cutting back or discontinuing some once the pump was implanted.The cause of the patient¿s symptoms, intubation, and being sent to the icu was attributed to the patient continuing on pain medications despite being implanted with the pump.The patient¿s issue had resolved (per the hcp on (b)(6) 2017).The patient was extubated and had been doing much better.The patient¿s status was alive ¿ no injury.The patient¿s medical history was unavailable.There were no further complications reported or anticipated.

Manufacturer Narrative

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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6561067
• MDR Text Key: 74986785
• Report Number: 3004209178-2017-10128
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2017
• Date Device Manufactured: 03/23/2017
• 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: 77 YR