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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 8637-20
Device Problems Electromagnetic Interference (1194); Mechanical Jam (2983)
Patient Problem Pain (1994)
Event Date 08/22/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare professional on (b)(6) 2018 indicated the patient's weight was unknown. It was reported that the motor stall recovery occurred on (b)(6) 2017 at 07:36. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare provider via a clinical study reported the device was interrogated, on (b)(4) 2018, and a motor stall was found in the log report. The event date of the motor stall was (b)(4) 2017. It was indicated the event was related to the device or therapy. No action was taken and the issue resolved without sequelae on (b)(4) 2017.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. 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 morphine 5mg/ml at 0. 7mg/day via an implantable pump. The indication for use was intractable spasticity. It was reported that a motor stall was seen at initial interrogation. The patient recently had an mri. The healthcare provider reported the patient had an mri yesterday and the pump has not recovered yet. The pump was still alarming as of today. The healthcare provider stated that she had programmed a single bolus to see if the motor stall would recover but it had not. The patient had an increase in pain. The healthcare provider stated she would continue to check the pump and if it didn¿t recover today she would bring the patient back tomorrow. No further patient complications were reported.
 
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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 Key6827006
MDR Text Key128638717
Report Number3004209178-2017-18334
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00613994779229
UDI-Public00613994779229
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 Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 11/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2013
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received11/15/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/29/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0591-2009

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