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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 Problems Improper or Incorrect Procedure or Method (2017); Insufficient Flow or Under Infusion (2182); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Sleep Dysfunction (2517)
Event Date 05/19/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_prog, serial#: unknown, product type: programmer, physician. Other relevant device(s) are: product id: neu_unknown_prog, serial/lot #: unknown. 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 was receiving morphine of an unknown concentration at an unknown dose rate via an implantable pump for non-malignant pain and chronic low back pain. It was reported that the patient had second thoughts on getting another pump. When he went in to get a refill, they stated the battery was dead and there was still a lot of morphine left in the pump. The patient was not in pain at that time. They took out the morphine and the patient left tuesday after the appointment. That night and wednesday, the patient had pain like he never had in his life. It was further noted that they put morphine back into pump and used two different gauges, and they wondered if it was even working. They gave the patient oxy and valium and the patient wondered if there was something he could take for the pain. The patient could not get surgery for a month and he was on a list for this. It was further reported that they determined the pump was dead and the patient was at 7 years as of (b)(6) 2020. Up until that day the patient was not in pain, so the patient stated the pump must have been working. The patient could not sleep and was just moaning. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product id: neu_unknown_prog, serial# unknown, product type: programmer, physician. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare provider (hcp) via a device manufacturer representative regarding a patient indicated that the pump had reached end of service and the patient experienced withdrawal symptoms. It was noted that the patient was non-compliant had not scheduled a replacement surgery. Surgery was planned for (b)(6) 2020. The issue was currently unresolved and the patient was alive with no injury. No further 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)
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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10094615
MDR Text Key192383999
Report Number3004209178-2020-09246
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,consum
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 05/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2014
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/12/2013
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: 05/27/2020 Patient Sequence Number: 1
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