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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION MEDTRONIC (INTRATHECAL PAIN PUMP) SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC NEUROMODULATION MEDTRONIC (INTRATHECAL PAIN PUMP) SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problem Battery Problem (2885)
Patient Problem Insufficient Information (4580)
Event Date 10/14/2021
Event Type  malfunction  
Event Description
Patient had continuous complaints of cyclical withdrawal symptoms with her medtronic pain pump. A referral was made on (b)(6) 2021 to have it replaced, but the symptoms had been over the last approximate 6 months when the battery end of life was still appropriate. Fda safety report id # (b)(4).
 
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Brand NameMEDTRONIC (INTRATHECAL PAIN PUMP) SYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
MDR Report Key13479727
MDR Text Key285493753
Report NumberMW5107268
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/07/2022 Patient Sequence Number: 1
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