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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 Excess Flow or Over-Infusion (1311); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Diarrhea (1811); Dyspnea (1816); Nausea (1970); Overdose (1988); Seizures (2063); Vomiting (2144); Loss of consciousness (2418); Cognitive Changes (2551); Lethargy (2560); Test Result (2695)
Event Date 02/28/2018
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 professional (hcp) regarding a patient who was receiving morphine at an unknown dose and concentration via an implantable infusion pump for non-malignant pain. It was reported that the patient had dementia so their baseline is confusion. It was reported that the patient's pump was refilled on (b)(6) 2018 and the patient was admitted to the hospital on (b)(6) 2018 with nausea, vomiting, and diarrhea. It was reported that the patient had high carbon dioxide levels and was maybe not breathing appropriately. It was reported the patient was lethargic and obtunded and had seizures the night of (b)(6) 2018. The hcp had inquired about turning the pump off. No further complications were anticipated/reported. On (b)(6) 2018 telph, (hcp): additional information was received from a healthcare professional (hcp). The hcp reported the patient was lethargic/unresponsive, and the doctors believed the cause was that maybe the pump was delivering too much medication. It was reported a pain doctor came in and decreased the morphine by 10%. After that the patient showed improvement in their symptoms. The hcp reported the patient was discharged from the hospital so they assume the patient had recovered. The patient's weight was (b)(6). No further complications were anticipated/reported.
 
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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 Key7380478
MDR Text Key103778463
Report Number3004209178-2018-05965
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
Remedial Action Notification
Type of Report Initial
Report Date 03/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/14/2016
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 Received03/01/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/16/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1570-2014

Patient Treatment Data
Date Received: 03/28/2018 Patient Sequence Number: 1
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