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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 8637-40
Device Problems No Audible Alarm (1019); Premature End-of-Life Indicator (1480)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/13/2020
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a foreign manufacturer representative on (b)(6) 2020 regarding a patient receiving hydromorphone (20mg/ml at 3. 2mg/day) via an implanted infusion pump. It was reported that the patient's end of service (eos) date had changed unexpectedly. The patient was in clinic on (b)(6) 2020 and the pump read that elective replacement indicator (eri) was less than one month and was scheduled to occur in (b)(6) 2020. Eri was normal based on the implant date. The patient did not want their pump replaced so they began titrating the patient's dose down weekly. Pump logs read that eri had occurred on (b)(6) 2020, and the reports from 2020-jul-23 stated that eos was scheduled to occur on (b)(6) 2020. The pump report on 2020-aug-06 also stated that eos would occur on (b)(6) 2020, however, on 2020-aug-13 the tablet indicated that eos was scheduled to occur on (b)(6) 2020 (the date of interrogation). The pump was not alarming. The pump was interrogated with an old model programmer which read that the pump would reach eos on 2020-jul-31. It was confirmed that both programmers had the correct date. The patient was not symptomatic. No further complications were reported or 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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10408865
MDR Text Key202982739
Report Number3004209178-2020-14123
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2014
Device Model Number8637-40
Device Catalogue Number8637-40
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 Received09/25/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/03/2013
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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