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

Model Number 8637-40

Device Problem Device Alarm System (1012)

Patient Problems Low Blood Pressure/ Hypotension (1914); Overdose (1988); Lethargy (2560)

Event Date 01/25/2019

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 healthcare provider via a company representative regarding a patient who was receiving morphine with concentration 25 mg/ml at a dose rate of 5.99 mg/day and clonidine with concentration 800 mcg/ml at dose rate of 191.85 mcg/day via an implantable pump for non-malignant pain.It was reported that the patient presented to the emergency room hypotensive and lethargic.The event occurred during normal use.Regarding environmental/external/patient factors that may have led or contributed to the issue, it was noted that the patient thought he heard his pump alarm and used his personal therapy manager (ptm), which he never normally used.It was further indicated that the pump logs showed the patient used his ptm twice that morning.The pump logs were read and there was no recorded alarm or issue with the pump.The logs showed 2 successful boluses given on (b)(6) 2019.The company representative was contacted by the hcp to aid with adjusting the pump.After the company representative arrived at the account, the logs were read and ptm usage was discussed.It was further noted that the patient¿s blood pressure had stabilized and they were no longer lethargic.No pump adjustment was requested.No surgical intervention was performed or planned.The issue was resolved at the time of the report.The patient was without injury regarding their status at the time of the report.Other medications (oral, etc.) the patient was taking at the time of the event was unable to be obtained.The patient¿s medical history was indicated as having been requested but was unknown.It was noted that the patient was to follow-up with their managing physician.No further patient complications have been reported as a result of this event.

• 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: 8348082
• MDR Text Key: 136483791
• Report Number: 3004209178-2019-03434
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2018
• 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: 01/25/2019
• Date Device Manufactured: 01/09/2017
• 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): Other
• Patient Age: 44 YR
• Patient Weight: 159