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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 Fluid/Blood Leak (1250); Excess Flow or Over-Infusion (1311); Volume Accuracy Problem (1675); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscle Weakness (1967); Overdose (1988); Dizziness (2194); Loss of consciousness (2418)
Event Date 04/01/2018
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) via a manufacturer's representative (rep) regarding a patient receiving an unknown drug via an implantable infusion pump for non-malignant pain. It was reported that a few says ago the hcp was filling the pump and "within minutes afterwards the patient started to feel woozy and went limp. " the patient went to the hospital and went on a narcan drip. The hcp was confident it was not a pocket fill as they were able to withdraw what they put in. The rep said the patient was doing fine now and no further complications were expected or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare professional (hcp) via a manufacturer's representative (rep). It was reported that the patient had a potential pocket fill by a nurse while having the pump filled. The next time the hcp tried to fill the pump, the same thing happened where the patient "went out", there was 10 ml missing of drug when withdrawn. The physician stated the needle was in the reservoir and thought the pump leaked medication out during fill. It was unknown what if any environmental/external/patient factors may have led or contributed to the issue. The patient's pump was filled with normal saline and the plan was to explant. The issue was not resolved at the time of this report, the patient's status was "alive - no injury".
 
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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 Key7433045
MDR Text Key105560428
Report Number3004209178-2018-08113
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169100831
UDI-Public00643169100831
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,Followup
Report Date 06/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2016
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 Received06/12/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/11/2014
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: 04/16/2018 Patient Sequence Number: 1
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