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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 Problem Volume Accuracy Problem (1675)
Patient Problems Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)
Event Date 01/01/2017
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 consumer regarding a patient who received fentanyl (89. 9mcg/ml, 1849. 4mcg/day) and bupivacaine (0. 53 3mg/ml, 11. 381mg/day) in an implantable pump for spinal pain. A volume discrepancy occurred. The exact volumes were unknown. When the health care provider (hcp) withdrew the old medication before refilling, there was "3 times" the amount of medication then there was expected. The refill took place at the end of february - beginning of (b)(6) 2018. There were no previous volume discrepancies reported. The patient wanted to know the cause of the issue. The patient's managing hcp would not answer their questions and had not indicated any follow-up actions to address the issue. The patient experienced more episodes where they wanted to "jump out" of their skin over the last two months. The patient indicated this was the "first stage of when you start detoxing. " it was further stated the patient knew between 5 and 7 years the pump can start to go "flukey. " the patient's hcp had been decreasing the fentanyl and increasing the bupivacaine dose due to "some new statute from the medical board. " no further information was provided.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a consumer (con). It was reported that the patient thought something was wrong with the pump, like the battery was going or something. During the patient's last two refills , there had been more drug left than should have been. The first time was 3 times the amount and the second was not quite 3x. The patient stated the doctor did not address why, that possibly the math was off. The patient spoke with someone from the manufacturer who said there was a possibility of a catheter issue. About six months ago, the patient had been having instances where she feels like jumping out her skin and it had been getting stronger, more frequent. The patient's next refill was (b)(6)2018. About three years ago the patient was given medication for a migraine, unrelated to the pump, that caused a complete break/memory loss for over a year and the patient's memory was still spotty. The m edication started with a "t".
 
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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 Key7425317
MDR Text Key105678858
Report Number3004209178-2018-07880
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 consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2013
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/20/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/19/2012
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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