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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNROMED/MEDTRONIC INTRATHECAL PAIN PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC NEUROMODULATION SYNROMED/MEDTRONIC INTRATHECAL PAIN PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number SYNCHROMED II 8637-20
Device Problem Premature End-of-Life Indicator (1480)
Patient Problem Insufficient Information (4580)
Event Date 11/11/2021
Event Type  malfunction  
Event Description
Patient has a medtronic intrathecal pain pump. The estimated replacement for battery end of life was (b)(6) 2022. As soon as the system was interrogated with the appropriate device, it showed the pump therapy was out of service. After this error, you could no longer interrogate the system any longer. This pump failure occurred before the replacement estimation by 9 months. Product not available for evaluation until the pump is explanted with a new one to replace it. Fda safety report id # (b)(4).
 
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Brand NameSYNROMED/MEDTRONIC INTRATHECAL PAIN PUMP
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
MDR Report Key12835166
MDR Text Key281110527
Report NumberMW5105407
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
Type of Report Initial
Report Date 11/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSYNCHROMED II 8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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