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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 Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)
Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)
Event Date 05/12/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id th90t01, serial# (b)(4), product type mobile platform. Other relevant device(s) are: product id: th90t01, serial/lot #: (b)(4), ubd: 03-aug-2019, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient receiving demerol via an implanted infusion pump. It was reported that starting "like tuesday or wednesday" last week patient started experiencing withdrawal symptoms and suspected that their pump was low. It was noted the patient wasn't able to deliver a bolus because the handset had a message that stated "everything is low". The patient was not hearing an alarm coming from the pump but when they went for a refill they were told the pump was "practically empty".
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10075122
MDR Text Key192208831
Report Number3004209178-2020-08887
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 consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2020
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 Received06/08/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/21/2018
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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