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U.S. Department of Health and Human Services

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

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MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Pumping Stopped (1503); Application Program Problem (2880)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/29/2019
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 (hcp) on (b)(6) 2019 regarding a patient receiving hydromorphone (15mg/ml at 6. 496mg/day) and bupivacaine (10mg/ml at 4. 331mg/day) via an implanted infusion pump. The indications for use included non-malignant pain and chronic low back pain. It was reported that a motor stall occurred on (b)(6) 2019 at 10:25 with no recovery per event logs. The patient tried to utilize their personal therapy manager and confirmed code 8476. It was noted that the patient had an ultrasound on (b)(6) 2019 and didn't know if there was a magnetic resonance imaging (mri) suite next to where the ultrasound took place. It was noted that the elective replacement indicator (eri) was at 22 months. The patient was going to follow-up with a surgeon to replace the pump and catheter. Per the hcp, the patient was concerned about withdrawal and wanted to know if there would be other medication she could take because she did not want to go through withdrawal. A manufacturer representative later noted that the pump was being replaced on (b)(6) 2019. It was noted that the representative was in the middle of the case and was reading the event logs of the pump, but she was not seeing that a motor stall occurred. It was confirmed that the representative could see event logs back to (b)(6) 2019 and there was no motor stall, however, there was a recovery noted on (b)(6) 2019 at 06:22pm. It was confirmed that the representative was using the tablet to view the logs, and the correct patient was interrogated. No patient symptoms were reported and no further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed. The returned pump was interrogated and as per the logs the following medications were being administered as of (b)(6) 2019: hydromorphone with concentration 15. 0 mg/ml at a dose rate of 0. 720 mg/day and bupivacaine with concentration 10. 0 mg/ml at a dose rate of 0. 480 mg/day. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received via a healthcare provider. The patient's weight at the time of the event was clarified.
 
Manufacturer Narrative
Product id: 8780, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2019, product type: catheter; product id: 8780, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2019, product type: catheter. Section 'device' information references the main component of the system. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 06-dec-2015, udi#: (b)(4). Analysis revealed pump motor and gear train anomalies related to corrosion and/or wear and/or lubrication, and stall due to shaft-bearing. Analysis of the catheter body found damage to the transition tube. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer (Section G)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key8302345
MDR Text Key134912538
Report Number3004209178-2019-02374
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 company representative,health
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2015
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/17/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0497-2013

Patient Treatment Data
Date Received: 02/04/2019 Patient Sequence Number: 1
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