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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 09/26/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received on (b)(4) 2017 from the manufacturer's representative. It was reported that no motor stall was logged. It was also reported that the patient's pump alarms ended and the patient elected not to return to the office for a telemetry. No further complications were reported.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from healthcare professional via manufacturer representative regarding a patient who was receiving baclofen (concentration 2000mcg/ml at a dose of 96mcg/day) via intrathecal drug delivery pump for intractable spasticity. It was reported the pump had a motor stall. A motor stall was seen at initial interrogation and motor stall recovery did not occur. It was reported that the patient did have a magnetic resonance imaging (mri) and it had been more than two hours since the patient exited the mri field. Technical services discussed re-interrogating the pump with logs. The rep would call the hcp to discuss rechecking the pump logs. No patient 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 Key6903306
MDR Text Key103478213
Report Number3004209178-2017-20308
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169100831
UDI-Public00643169100831
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
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2016
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 Received10/26/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/30/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0591-2009

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