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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 Pain (1994); Therapeutic Response, Decreased (2271)
Event Date 12/01/2017
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 patient regarding their implantable drug infusion device. The drugs being delivered were fentanyl (450. 2 ug), baclofen (unknown), dilaudid (hydromorphone), and lidocaine with unknown concentrations and doses. The reason for use was non-malignant pain and spinal stenosis. It was reported that the patient knows that she is getting the medication because she can feel it when she does a bolus, but lately she has been "hurting so dam bad" and she used to not hurt at all. The caller is wondering if her healthcare professional (hcp) may have turned off her continuous flow and she is only getting her bolus. The issue started in (b)(6) 2017. It was also reported that there was a volume discrepancy and the patient did not know the volume information. They ¿had a big storm in la and there was a shortage on drugs so the hcp decided to lower the dosage to help conserve what was in the pump. ¿ the patient thinks the pump almost ran out of medication but can¿t confirm if it actually went dry or not. They never heard any type of alarm or anything, however when they went to take out the remaining drug at the next refill, there was hardly anything to take out (which was much less than they were expecting). This issue occurred in 2018 ¿sometime this year. ¿ the patient the inquired about product specifications or information regarding pump longevity and warranty information. Typical longevity and warranty information was reviewed. They stated the ptm says she has 16 months left. It was reviewed that external equipment replacements are covered for life of pump (upon being in good withstanding with repairs/sends back damaged equipment if requested by repairs). The caller also states she doesn't want to get "in trouble" with her doctor and doesn't want these reported issues mentioned to the hcp. She said she doesn't want it to seem like she was saying something to the manufacturer that she shouldn't be saying. Patient registration services was called to update hcp name and patient phone number. There were no further complications reported/anticipated.
 
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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 Key7417161
MDR Text Key105320000
Report Number3004209178-2018-07412
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
Report Date 04/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2014
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 Received04/02/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/12/2012
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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