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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-20
Device Problems Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Aspiration Issue (2883)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)
Event Date 12/10/2015
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2015, product type: catheter. Information references the main component of the system. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: (b)(6) 2017, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider via a company representative regarding a patient who was receiving an dilaudid with concentration 40 mg/ml at a dose rate of 4 mg/day and bupivacaine with concentration 9 mg/ml at an unknown dose rate via an implantable pump for spinal pain. It was reported that the patient indicated she had not had much pain relief ever since the pump was implanted. The physician noticed large differences in volumes during refills the last 2 times the patient¿s pump was refilled. The event occurred during normal use. A catheter issue was noted. A catheter access study was completed. Catheter access was completed and they were ¿unable to fluid¿. The date of the event/difficulty was (b)(6) 2018. There were no known environmental/external/patient factors that may have led or contributed to the issue. The issue was not resolved at the time of the report. Surgical intervention was planned but had not been scheduled. The patient was without injury at the time of the report. The patient¿s medical history was not available due to legal/confidential reason. Other medications the patient was taking at the time of the event was unable to be obtained. On (b)(6) 2018 additional information was received from a hcp via a company representative. It was clarified that regarding the catheter access study, they could not pull fluid and they did not attempt to push. Regarding the large difference in volumes during the last two refills, it was clarified that two times ago there was a difference of 5 ml more then expected. At the last refill there was 10 ml more then expected. No surgical intervention was planned at this time. They physician was to continue to decrease the dose and maybe wean to oral medications. The volume discrepancies at refills and patient not having much pain relief was unresolved. The patient¿s device remained implanted. Mo further patient complications have been reported as a result of this event.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7545999
MDR Text Key109516512
Report Number3004209178-2018-11932
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169100831
UDI-Public00643169100831
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 05/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2017
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 Received05/21/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/28/2015
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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