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U.S. Department of Health and Human Services

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

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MDT PUERTO RICO OPERATIONS CO SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problem Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/13/2017
Event Type  malfunction  
Event Description
Information was received from a health care provider (hcp) regarding a patient with an implantable drug infusion pump indicated for non-malignant pain and failed back surgery syndrome.The pump contained fentanyl [50 mcg/ml] at a dose of 12 mcg/day.It was reported a motor stall was seen at initial interrogation.The patient recently had an mri.A motor stall occurred on (b)(6) 2017 at 09:30.The hcp stated the patient left the mri field around 10 am that same day.It had not been less than 2 hours since the patient exited the mri field.The hcp stated their plan was to fill the patient¿s pump with saline and program it to minimum rate due to a pending back procedure the patient would be having in (b)(6).The hcp stated they were still not seeing the motor stall recovery.The hcp stated they would move forward with programming the pump to minimum rate with saline.The hcp stated she would not silence the alarm since it didn¿t bother the patient.No patient symptoms/complications were reported.
 
Manufacturer Narrative
Updated to reflect the patient's weight at the time of the event.Updated to reflect the information received on 2017-oct-10.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received on 2017-oct-10 from the patient's healthcare provider (hcp).The patient's weight was reported.It was reported that the issue was resolved pending the explant during the patient's scheduled back surgery on (b)(6) 2017.The patient's pump was refilled with normal saline and programs at minimal rate.No further complications were reported.
 
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Brand Name
SYNCHROMED II
Type of Device
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer (Section G)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6875287
MDR Text Key86638573
Report Number3004209178-2017-19590
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 health professional
Reporter Occupation Nurse
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/14/2015
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 09/14/2017
Initial Date FDA Received09/19/2017
Supplement Dates Manufacturer Received10/10/2017
Supplement Dates FDA Received10/16/2017
Date Device Manufactured11/18/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0592-2009
Patient Sequence Number1
Patient Age66 YR
Patient Weight103
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