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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. SYNCHROMED ® II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC, INC. SYNCHROMED ® II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-20
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/11/2019
Event Type  malfunction  
Event Description
Defective pain pump - device went into stall mode and never recovered.
 
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Brand NameSYNCHROMED ® II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC, INC.
710 medtronic parkway ne
minneapolis MN 55432
MDR Report Key9097796
MDR Text Key159411933
Report Number9097796
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-20
Device Catalogue Number863720
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/16/2019
Device Age3 YR
Event Location Hospital
Date Report to Manufacturer09/20/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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