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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 Problem Volume Accuracy Problem (1675)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/29/2011
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 consumer regarding a patient receiving lioresal (2000. 0 mcg/ml at 753. 4 mcg/day) via an implanted pump. The indication for use was intractable spasticity. It was reported the patient was scheduled to have a pump replacement surgery on may 3rd, and there were orders to do a dye study and assess the catheter because the nurse always pulls out more than double the volume of what should be in the pump. The examples were 2ml expected but pulled put 8 ml, 5. 1 expected but pulled out 9. 5 ml, and 4. 3 ml expected and pulled out 10 ml. It was noted the patient had the volume discrepancies since the pump was placed. There were no symptoms reported related to the volume discrepancies. It was mentioned that a x-ray was performed on (b)(6) 2013 and a dye study was performed on (b)(6) 2013 with no discrepancies noted. The cause of the discrepancies was not determined as nothing ever showed on the x-ray or dye study. It was reported the patient was having their pump replaced, on (b)(6) 2018, and ordered for the catheter to be checked during the replacement surgery. It was noted the patient was wheelchair bound and unable to get a weight. The office does not have the special scale for wheelchairs.
 
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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 Key7476312
MDR Text Key107001511
Report Number3004209178-2018-09725
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
Type of Report Initial
Report Date 05/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2013
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 Received04/26/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/10/2011
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: 05/01/2018 Patient Sequence Number: 1
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