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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems No Audible Alarm (1019); Pumping Stopped (1503); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/16/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider regarding a patient receiving bupivacaine 5mg/ml at 0. 7502mg/day and morphine 10mg/ml at 1. 5mg/day via an implantable pump. The indication for use was malignant pain. The healthcare provider reported a motor stall was seen at initial interrogation. The patient did recently have an mri. Per the healthcare provider today, (b)(6) 2018 at the pump refill a motor stall message was confirmed and via the event logs it occurred (b)(6) 2018 with the tube set message on (b)(6) 2018. The patient¿s mri occurred (b)(6) 2018 and the pump had not been read until today. There had been no audible alarms per the healthcare provider and inquired about it (intrathecal) dose adjustment due the motor stall. Telemetry mode was reviewed and the healthcare provide would follow the recommendations to confirm the motor stall recovery. No patient symptoms and no further complications were reported.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, 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 Key7384943
MDR Text Key104025259
Report Number3004209178-2018-06084
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Notification
Type of Report Initial
Report Date 03/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/30/2018
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2018
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/26/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0592-2009 Z-0497-2013

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