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U.S. Department of Health and Human Services

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

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MEDTRONIC, INC. SYNCHROMED II PUMP, INFUSION, IMPLANTED Back to Search Results
Model Number 8637-40
Device Problem Defective Device (2588)
Patient Problem Missed Dose (2561)
Event Date 12/17/2018
Event Type  malfunction  
Event Description
Patient had been to his pain management clinic for a routine pump refill. Pain md noted that the pump had stopped and sent patient to the emergency room for concern monitoring the patient for drug withdrawal (pump had dilaudid, baclofen, and fentanyl). Patient was admitted to icu and given oral meds until surgery to explant the malfunctioning pump and implant a new pump. The surgeon suspected a pump motor stall.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED
Manufacturer (Section D)
MEDTRONIC, INC.
7000 central ave., n.e.
minneapolis MN 55432
MDR Report Key8324947
MDR Text Key135703429
Report Number8324947
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 01/29/2019,01/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/11/2019
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
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/29/2019
Device Age5 YR
Event Location No Information
Date Report to Manufacturer02/11/2019
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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