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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC NEUROMODULATION SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637
Device Problems Material Too Rigid or Stiff (1544); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/17/2018
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 8780, lot# 0205540503, implanted: (b)(6) 2012, explanted: (b)(6) 2018, product type: catheter. Information references the main component of the system. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: , udi#:. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving lioresal [2000 mcg/ml] at an unknown dose via an implantable pump for multiple sclerosis. It was reported that during a pump replacement due to end of service (eos) when connecting the pump they noticed that the catheter was very stiff where it enters into the connector and the surgeon thought it was fractured. He removed and cut this part of the catheter and connected a new connector. It was indicated the catheter would be returned. The patient had no symptoms. There were no environmental/external/patient factors that may have led or contributed to the issue. No diagnostics or troubleshooting was performed. At the time of the report the issue was resolved and the patient status was "alive - no injury. " no further complications were reported or anticipated.
 
Manufacturer Narrative
Lot number of the catheter was reported as (b)(4) but the ubd and udi are not available as this is not a valid lot number. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received noted that the pump would not be returned as it was disposed of since there was no issue with the pump.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7798840
MDR Text Key117701825
Report Number3007566237-2018-02481
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637
Device Catalogue Number8637
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/05/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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