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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Loss of consciousness (2418)
Event Date 08/28/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving fentanyl (500 mcg/ml at 40. 06 mcg/day) via an implanted pump. The indication for pump use was spinal pain. It was reported that the er (emergency room) physician contacted the national answering service on saturday requesting that the pump dose be lowered because they felt that the patient was being overdosed. The environmental, external, or patient factors that may have led or contributed to the issue were noted to be that the patient had dementia and had just had the medication in the pump changed from morphine to fentanyl on (b)(6) 2021. The pump was interrogated and seemed to be operating normally. The doctors in the er decided to lower the dose by 10% and the patient seemed to do better and was released due to no icu (intensive care unit) beds. The next day (sunday), the patient was again found non-responsive by his wife and had fallen. Ems (emergency medical services) took the patient to the er a second time. This time the pump dose was reduced by 55. 5% by the er doctors. It was unknown if the issue was resolved.
 
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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 Key12494083
MDR Text Key272109364
Report Number3004209178-2021-14074
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,health
Reporter Occupation
Type of Report Initial
Report Date 09/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/28/2020
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 Received08/28/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/30/2018
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: 09/20/2021 Patient Sequence Number: 1
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