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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Application Program Problem (2880); Aspiration Issue (2883)
Patient Problem Muscular Rigidity (1968)
Event Type  Injury  
Manufacturer Narrative
Refers to the main device, other components include: product id 8709sc, serial# (b)(4), implanted: (b)(6) 2008, product type catheter.
 
Event Description
Information was received from a healthcare provider (hcp) via a manufacturer's representative (rep) regarding a patient who was receiving baclofen at an unknown concentration and dosage and morphine at an unknown concentration and dosage via an implantable pump for intractable spasticity.On (b)(6) 2017, it was reported it was reported that the patient's catheter could not be aspirated and the pump rotors did not appear to rotate during a rotor study.It was noted that a motor stall was not reported or confirmed through the pump logs.The patient also reported increased spasticity.It was confirmed that a dye study and a rotor study had been performed.It was planned that the system would be replaced.It was unknown what, if any, environmental/external/patient factors that may have led or contributed to the issue.The cause of the inability to aspirate the catheter and the pump rotors not rotating was not determined.It was noted that the hcp may know more, specifically about the catheter, when the system is replaced.The rep noted that they would collect the pump and catheter at the replacement to send back to medtronic for analysis.The issue was not considered resolved at the time of the report.The patient's status was listed as "alive-no injury".No further complications were reported.
 
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Brand Name
SYNCHROMED II
Type of Device
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7038361
MDR Text Key92300937
Report Number3004209178-2017-23895
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169100824
UDI-Public00643169100824
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 11/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/28/2016
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/08/2017
Initial Date FDA Received11/16/2017
Date Device Manufactured07/31/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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