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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 Failure To Service (1563); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 06/03/2018
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 8840, serial# unknown, product type: programmer, physician. Information references the main component of the system. Other relevant device(s) are: product id: 8840, serial/lot #: unknown, ubd: , udi#: if information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) regarding a patient receiving morphine (10 mg/ml at 1. 395 mg/day) via an implanted pump. The indication for pump use was non-malignant pain. On (b)(6) 2018 it was reported that the empty pump alarm was occurring. The patient had missed their pump refill visit because they were not able to get transportation. The patient experienced withdrawal which had come on suddenly. Per the hcp, the patient did not want the pump anymore and they had been in the process of weaning the patient off the medication and eventually removing the pump. Because of this, they wanted to stop the alarm and discontinue the use of the pump now. The option of turning the pump off was reviewed. The hcp chose to program the pump to minimum rate mode and program a full reservoir volume. No further complications were reported/anticipated.
 
Manufacturer Narrative
Concomitant medical products: product id 8840, serial# (b)(4), product type: programmer, physician. The main component of the system, other relevant device(s) are: product id: 8840, serial/lot# (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received on 25-jun-2018 and 26-jun-2018 from the healthcare professional (hcp) who reported that at the visit on (b)(6) 2018, the pump reservoir was filled with saline and then programmed to run at minimum rate. The patient had since come back to the office and bupivacaine was put in the pump. The patient was doing well, and everything had been fine since adding the bupivacaine. No further complications were reported/anticipated.
 
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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 Key7586081
MDR Text Key110578127
Report Number3004209178-2018-13036
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,Followup
Report Date 06/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2015
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 Received06/25/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/18/2014
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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