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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 8637-40
Device Problem Volume Accuracy Problem (1675)
Patient Problem Muscle Spasm(s) (1966)
Event Date 08/22/2018
Event Type  malfunction  
Event Description
Patient presents for intrathecal pump dye study. She has had increased spasticity and increased residual pump volumes. Pre-procedure interrogation of pump revealed motor stall has occurred. The pump has failed and needs to be replaced. Patient thinks it started beeping this past weekend. Risk of delaying replacement includes death, and this has been told to the patient. A copy of the log has been provided.
 
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Brand NameSYNCHROMED® II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC, INC.
7000 central ave., n.e.
minneapolis MN 55432
MDR Report Key7881642
MDR Text Key120456052
Report Number7881642
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 08/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-40
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/29/2018
Event Location No Information
Date Report to Manufacturer09/17/2018
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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