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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SYNCHROMED II 8637-40 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC SYNCHROMED II 8637-40 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/04/2017
Event Type  malfunction  
Event Description
I received only two warning alarms before the infusion pump went out. It stalled out after one of those alarms but took 6 hrs to recover. In approx 8 to 10 hrs later. It stalled again and never recovered. The attending physician was told by the pump company to turn the infusion pump off. This then stopped all therapy i was receiving for a very serious back injury. As of this date (b)(6) 2017, i am still waiting for replacement of this infusion pump.
 
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Brand NameSYNCHROMED II 8637-40
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC
MDR Report Key6787546
MDR Text Key82607457
Report NumberMW5071502
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-40
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/09/2017 Patient Sequence Number: 1
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