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 Fever (1858); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930)

Event Date 09/27/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 8780, lot# serial# (b)(4), implanted: (b)(6) 2018, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 22-aug-2015, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a company representative (rep) via a healthcare provider (hcp) regarding a patient with an implantable infusion pump receiving baclofen (loiresal) with a concentration of 2000 mcg/ml and a dose of 800 mcg/day for intractable spasticity and head/brain injury. It was mentioned hcp stated patient had spinal surgery last week and the patient had tachycardia, agitation and hypertension post surgery. Hcp stated the patient has been hospitalized since the surgery. Hcp stated on friday of last week they did a cap aspiration to check the catheter and were able to aspirate freely from the cap and re-primed the tcv. Hcp stated patient had some hypotension post aspiration and since he has had a fever, hypotension and hypertension. Hcp stated today they attempted a cap dye study and were only able to aspirate 0. 8ml of fluid. Hcp was wondering about re-priming now. Hcp stated they are going to rule out infection also.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12666878
• MDR Text Key: 277464953
• Report Number: 3004209178-2021-15624
• Device Sequence Number: 1
• Product Code: LKK
• 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

• Type of Report: Initial
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 01/28/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/06/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 08/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/20/2021 Patient Sequence Number: 1