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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 8637-20
Device Problems No Audible Alarm (1019); Mechanical Jam (2983)
Patient Problem Muscle Spasm(s) (1966)
Event Date 05/12/2018
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) regarding the patient¿s implantable drug infusion device. The drug being delivered was 4,000 mcg/ml baclofen (unknown) at 1,185 mcg/day. The reason for use was intractable spasticity and cerebral palsy. It was reported that there was a motor stall post mri (magnetic resonance imaging) with no audible pump alarms. The mri was not performed due to a problem with the device or therapy. It was reviewed the pump alarm interval should be 10 minutes, and it was 1 hour. The manufacturer¿s representative (rep) programmed the pump at 1 hour critical alarm interval during implant. The caller stated the patient's pump motor stall saturday ((b)(6) 2018) was due to the mri that was done on that same day per the doctor's request to re-diagnosis the patient¿s infantile cp (occurred when patient was an infant) and that the patient had this diagnosis previous to the pump implant. They were not suspecting a device or therapy issue as the reason for the mri. The pump was not currently alarming per the patient/family/hcp but the patient was "more spastic," erratic and their arms were flailing. These issues began on (b)(6) 2018 post mri. ¿the patient is regularly given 10 mg/baclofen po in the morning, every morning. ¿ the caller was unable to confirm pump status post mri because of the 8840 issue. Technical services troubleshooted with the caller reviewing pertinent info per the caller¿s inquiries. The managing hcp had the most information regarding this event. There were no further complications reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the hcp on 2018-may-29. It was reported that an mri was done, no pump stall was reported. It was seen by outside nursing and they postulated his clinical signs and ontology due to reason of the stall. The hcp never documented a stall. No actions were taken to resolve the no audible pump alarms, ¿dosaging change to help. ¿ the issue of no audible pump alarm was resolved. The patient¿s weight at the time of the event was unknown. There were no further complications reported/anticipated.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, 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 Key7535017
MDR Text Key109372135
Report Number3004209178-2018-11569
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2014
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 Received05/29/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/22/2013
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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