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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 Improper or Incorrect Procedure or Method (2017); Application Program Problem (2880)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2018
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: a810, product type: software. Other relevant device(s) are: product id: a810. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a health care provider (hcp) regarding a patient who received an unknown drug in an implantable pump for unknown indication for use. During programming a bolus with the clinician programmer tablet, the dosing information changed on its own. The hcp had reported the issue to the manufacturer representative months ago. The reporter did not remember all the processes that were witnessed at the time. No symptoms were reported. No further information was available. Additional information was received from a manufacturer representative. It was reported that the manufacturer representative was not made aware of this issue with the tablet. There were no further complications reported at this time. Additional information was received from a hcp. It was reported that the approximate date on which the event occurred was (b)(6) 2019. The dosing change was noticed before the patient had left the appointment. The patient did not experience any symptoms. A 8840 programmer was used to resolve the programming issue. The patient was originally programmed for baclofen (1800mcg/ml at 649. 6mcg/day). During programming, the drug information was changed to baclofen (2160mcg/ml at 935. 8mcg/day). The basal rate went from 349. 3mcg (14. 9mcg/hr) to 636. 1mcg (27. 1mcg/hr); the flex bolus doses and rate did not change. Another programming session with the 8840 programmer changed the basal rate to 14. 9mcg/hr (daily dose was 651mcg/day). There were no further complications reported at this time.
 
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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 Key8329450
MDR Text Key137559098
Report Number3004209178-2019-02897
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
Type of Report Initial
Report Date 02/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2013
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 Received01/31/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/21/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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