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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 8637-20
Device Problem Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/25/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp). The mri was performed on (b)(6) 2017. Action taken regarding the motor stall was multiple pump scans; alarm reset; reprogramming. After 30 minutes reset occurred. The motor stall event has been resolved. The patient¿s pump had delivered the correct volume of medication which was noted during a refill. The patient weight was approximately 128 pounds. Patient medical history was multiple sclerosis.
 
Event Description
Information was received from a healthcare professional (hcp) regarding a patient who was receiving lioresal 500 mcg/ml; 73 mcg/day via an implantable pump. Indication for use was intractable spasticity. The date of the event was (b)(6) 2017. It was reported the patient recently had magnetic resonance imaging (mri). The patient did not come back to have the pump interrogated on the day he had the mri. The mri was not due to a suspected problem with the device or therapy. A motor stall was seen at initial interrogation. A motor stall recovery did not occur. It had not been less than two hours since the patient exited the mri field. No symptoms were reported. No further complications were reported.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, 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 Key6846406
MDR Text Key103335880
Report Number3004209178-2017-18843
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169508149
UDI-Public00643169508149
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2017
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received09/22/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/13/2016
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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