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); Oversedation (1990); No Known Impact Or Consequence To Patient (2692)

Event Date 12/21/2018

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 manufacturer¿s representative (rep) regarding the patient¿s implantable drug infusion device.The drugs being delivered were 2,000 mcg/ml fentanyl at 750.2 mcg/day, 0.8 mg/ml bupivacaine at 0.3 mg/day, and 1.0 mg/ml dilaudid at 0.375 mg/day.The reason for use was non-malignant pain.It was reported that on (b)(6) 2018 the patient had an unrelated surgical procedure and as of the morning of (b)(6) 2018 the patient had her blood pressure drop and was showing over sedation.The patient was in the icu.Non-reservoir drugs included percocet 10 mg given on (b)(6) 2018 as well.The ptm has not been used since (b)(6) 2018 per the logs.The rep states he was called to the facility to read the pump.It was explained that it is up to the managing physician or physician in charge of the patient care at the hospital to distinguish what dose per day should be programmed if they want to decrease the dose on the pump.The rep does not know the healthcare professional (hcp) information and it was explained that the managing physician should be consulted once they know who that is.There were no further complications reported/anticipated.

Manufacturer Narrative

¿review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event no longer meets the reporting requirements stipulated in 21 cfr 803.¿ if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the rep on 2019-jan-08.It was reported that the cause of the blood pressure drop and the over sedation were due to total hip replacement on (b)(6) 2018.Actions taken to resolve the issue included having the pump daily dose reduced per the doctor¿s instruction.The issue had been resolved and the current status of the device is ¿working properly.¿ there were no further complications reported/anticipated.***this event is no longer a reportable event.Mdr decision corrected to not reportable.No additional supplemental mdrs are required unless additional information received makes the event reportable.Due to gch functionality, the complaint flag cannot be flipped to ¿no¿ as a regulatory report exists in the this product 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: 8226360
• MDR Text Key: 132361333
• Report Number: 3004209178-2019-00458
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2019
• Date Device Manufactured: 10/24/2017
• 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): Life Threatening
• Patient Age: 54 YR